GENERATOR
This device is manufactured by ATS MEDICAL, CAREFUSION 207 DBA CAREFUSION, COOPERSURGICAL, CYBERONICS / LIVANOVA USA, EDWARDS LIFESCIENCES, HEART VALVES SANTA ANA, LIVANOVA USA, MEDTRONIC, MEDTRONIC ATS, MEDTRONIC HEART VALVES DIVISION, MEGADYNE MEDICAL PRODUCTS, MEGADYNE MEDICAL PRODUCTS / ETHICON ENDO-SURGERY, PHYSIO-CONTROL, SMITHS MEDICAL ASD, STRYKER CORP MEDICAL DIV, STRYKER CORP MEDICAL DIVISION, STRYKER INSTRUMENTS, STRYKER MEDICAL, STRYKER MEDICAL-KALAMAZOO, VYAIRE MEDICAL.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-07 | Injury | Post Operative Wound Infection | None |
| 2024-06-28 | Injury | Insufficient Information | None |
| 2024-06-04 | Injury | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2024-06-04 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-06-03 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-06-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2024-06-01 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-06-01 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-06-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-05-30 | Injury | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2024-05-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fracture |
| 2024-05-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Energy, Physical Resistance/Sticking |
| 2024-05-29 | Injury | Cardiac Arrest | Adverse Event Without Identified Device or Use Problem |
| 2024-05-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Energy, Physical Resistance/Sticking |
| 2024-05-28 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-05-28 | Malfunction | Dizziness, Convulsion, Clonic, Implant Pain | None |
| 2024-05-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Insufficient Information |
| 2024-05-24 | Injury | Neck Pain | Adverse Event Without Identified Device or Use Problem |
| 2024-05-24 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-05-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2024-05-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2024-05-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2024-05-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2024-05-22 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-05-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2024-05-18 | Injury | Wound Dehiscence, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-05-01 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-05-01 | Injury | Pocket Erosion, Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-05-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Shock/Stimulation |
| 2024-05-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | No Audible Prompt/Feedback, Device Sensing Problem |
| 2024-04-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inappropriate or Unexpected Reset |
| 2024-04-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up, Unexpected Shutdown |
| 2024-04-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Insufficient Information |
| 2024-04-18 | Injury | Bradycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-04-18 | Injury | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2024-04-18 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-15 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-04-10 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-04-10 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2024-04-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-04-04 | Injury | Impaired Healing | Adverse Event Without Identified Device or Use Problem |
| 2024-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2024-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Intermittent Loss of Power |
| 2024-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2024-04-01 | Malfunction | Ventricular Fibrillation | Failure to Deliver Shock/Stimulation |
| 2024-03-31 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-03-29 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-03-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Shock/Stimulation |
| 2024-03-25 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-03-24 | Injury | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2024-03-21 | Injury | Insufficient Information | None |
| 2024-03-21 | Injury | Post Operative Wound Infection | None |
| 2024-03-21 | Injury | Convulsion, Clonic | None |
| 2024-03-21 | Injury | Post Operative Wound Infection | None |
| 2024-03-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation |
| 2024-03-19 | Injury | Pocket Erosion, Skin Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-03-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2024-02-29 | Malfunction | Convulsion, Clonic | Failure to Interrogate |
| 2024-02-27 | Death | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-26 | Injury | Dysphagia/ Odynophagia, Paralysis, Cough | Adverse Event Without Identified Device or Use Problem |
| 2024-02-20 | Death | Cardiac Arrest | None |
| 2024-02-15 | Injury | Bradycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-02-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Energy, Physical Resistance/Sticking |
| 2024-02-12 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-02-06 | Injury | Dyspnea | Adverse Event Without Identified Device or Use Problem |
| 2024-02-06 | Injury | Erythema, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2024-02-05 | Injury | Implant Pain, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2024-02-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Display or Visual Feedback Problem |
| 2024-01-31 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-01-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Unexpected Shutdown |
| 2024-01-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Energy, Low impedance, Physical Resistance/Sticking |
| 2024-01-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Interrogate |
| 2024-01-29 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-01-23 | Injury | Vomiting | Adverse Event Without Identified Device or Use Problem |
| 2024-01-23 | Injury | Implant Pain, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2024-01-22 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-19 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-01-18 | Injury | Failure of Implant, Foreign Body In Patient, Implant Pain, Swelling/ Edema | None |
| 2024-01-18 | Injury | Anaphylactic Shock, Appropriate Term / Code Not Available | None |
| 2024-01-18 | Injury | Inflammation, Pain, Swelling/ Edema | None |
| 2024-01-10 | Injury | Nerve Damage, Discomfort, Partial Hearing Loss | Adverse Event Without Identified Device or Use Problem |
| 2024-01-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem |
| 2024-01-09 | Injury | Vomiting, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2024-01-09 | Injury | Paralysis | Adverse Event Without Identified Device or Use Problem |
| 2024-01-04 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-01-03 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2024-01-01 | Injury | Vomiting | Adverse Event Without Identified Device or Use Problem |
| 2023-12-29 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-12-28 | Injury | Wound Dehiscence, Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-12-24 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-12-22 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-12-13 | Injury | Unspecified Mental, Emotional or Behavioural Problem | Adverse Event Without Identified Device or Use Problem |
| 2023-12-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Interrogate |
| 2023-12-11 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-12-06 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-12-03 | Injury | Convulsion, Clonic | None |
| 2023-11-28 | Injury | Dysphagia/ Odynophagia | None |
| 2023-11-27 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-11-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-11-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Energy, Physical Resistance/Sticking |
| 2023-11-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-11-02 | Injury | Convulsion, Clonic, No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-10-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Key or Button Unresponsive/not Working |
| 2023-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Energy, Physical Resistance/Sticking |
| 2023-10-04 | Injury | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-10-02 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-10-02 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-02 | Injury | Pocket Erosion, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-09-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Sense |
| 2023-09-27 | Injury | Extreme Exhaustion | Adverse Event Without Identified Device or Use Problem |
| 2023-09-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inappropriate or Unexpected Reset |
| 2023-09-21 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up, Inappropriate or Unexpected Reset |
| 2023-09-20 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-09-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up |
| 2023-09-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Incomplete or Inadequate Connection |
| 2023-09-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Charge |
| 2023-09-11 | Malfunction | Convulsion, Clonic | Output below Specifications |
| 2023-09-05 | Injury | Discomfort | Adverse Event Without Identified Device or Use Problem |
| 2023-09-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up |
| 2023-09-01 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-08-25 | Injury | Dehydration, Post Operative Wound Infection, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-08-25 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-08-24 | Injury | Implant Pain, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-08-23 | Injury | Pocket Erosion, Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-23 | Malfunction | Convulsion, Clonic | Inappropriate or Unexpected Reset |
| 2023-08-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inappropriate or Unexpected Reset |
| 2023-08-21 | Injury | Bradycardia, Tachycardia, Syncope/Fainting | Adverse Event Without Identified Device or Use Problem |
| 2023-08-16 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-08-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Insufficient Information |
| 2023-08-16 | Injury | Wound Dehiscence | Adverse Event Without Identified Device or Use Problem |
| 2023-08-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Incomplete or Inadequate Connection |
| 2023-08-01 | Injury | Vomiting, Convulsion, Clonic, Discomfort | Adverse Event Without Identified Device or Use Problem |
| 2023-07-28 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Injury | Fever, Inflammation | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Injury | Depression | Adverse Event Without Identified Device or Use Problem |
| 2023-07-24 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-19 | Death | No Clinical Signs, Symptoms or Conditions | Failure to Sense |
| 2023-07-15 | Injury | Deformity/ Disfigurement | Appropriate Term/Code Not Available |
| 2023-07-13 | Injury | Pocket Erosion, Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-12 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up |
| 2023-07-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up |
| 2023-07-06 | Injury | Pocket Erosion, Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-06 | Injury | Neck Pain | Adverse Event Without Identified Device or Use Problem |
| 2023-07-05 | Injury | Paralysis | Adverse Event Without Identified Device or Use Problem |
| 2023-07-03 | Injury | Low Blood Pressure/ Hypotension, Syncope/Fainting | Adverse Event Without Identified Device or Use Problem |
| 2023-07-03 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-06-29 | Malfunction | Cardiac Arrest | Failure to Power Up |
| 2023-06-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2023-06-22 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-06-21 | Injury | Convulsion, Clonic, Status Epilepticus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up |
| 2023-06-15 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-06-14 | Injury | Hypoesthesia, Neck Pain | Adverse Event Without Identified Device or Use Problem |
| 2023-06-13 | Injury | Cardiac Arrest | Adverse Event Without Identified Device or Use Problem |
| 2023-06-08 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-06-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-06-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Interrogate |
| 2023-06-07 | Injury | Headache, Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-06-06 | Injury | Bradycardia | Adverse Event Without Identified Device or Use Problem |
| 2023-06-01 | Injury | Implant Pain | Adverse Event Without Identified Device or Use Problem |
| 2023-06-01 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-05-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2023-05-25 | Malfunction | Convulsion, Clonic, No Clinical Signs, Symptoms or Conditions | Failure to Deliver Energy, Output below Specifications, Physical Resistance/Sticking |
| 2023-05-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up |
| 2023-05-12 | Injury | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-05-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2023-05-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Self-Activation or Keying, Failure to Read Input Signal, Activation, Positioning or Separation Problem |
| 2023-04-26 | Injury | Atrial Fibrillation | Adverse Event Without Identified Device or Use Problem |
| 2023-04-24 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-04-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Arcing of Electrodes |
| 2023-04-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Interrogate |
| 2023-04-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Sense |
| 2023-04-11 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-04-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Insufficient Information |
| 2023-04-07 | Injury | Scar Tissue, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-04-05 | Malfunction | Convulsion, Clonic | Premature Discharge of Battery |
| 2023-04-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-04-04 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-03-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-03-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-03-28 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-03-28 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-03-28 | Injury | Discomfort, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-03-25 | Injury | Wound Dehiscence, Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-03-18 | Injury | Pocket Erosion, Seroma | Adverse Event Without Identified Device or Use Problem |
| 2023-03-10 | Injury | Apnea, Dyspnea | Adverse Event Without Identified Device or Use Problem |
| 2023-03-08 | Malfunction | Convulsion, Clonic, No Clinical Signs, Symptoms or Conditions | Low impedance, Physical Resistance/Sticking |
| 2023-03-07 | Injury | Pocket Erosion, Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-03-06 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-03-06 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-03-04 | Injury | Pocket Erosion | Adverse Event Without Identified Device or Use Problem |
| 2023-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Shock/Stimulation |
| 2023-02-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-02-16 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-02-15 | Injury | Unspecified Mental, Emotional or Behavioural Problem | Adverse Event Without Identified Device or Use Problem |
| 2023-02-14 | Death | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-02-13 | Injury | Bradycardia, Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-02-10 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-02-09 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-02-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Shock/Stimulation, Aborted Charge |
| 2023-02-01 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-01-30 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-01-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Connection Problem |
| 2023-01-20 | Injury | Neck Pain, Implant Pain | Adverse Event Without Identified Device or Use Problem |
| 2023-01-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem, Failure to Power Up |
| 2023-01-12 | Injury | Discomfort | Adverse Event Without Identified Device or Use Problem |
| 2023-01-11 | Injury | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-01-09 | Death | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2023-01-06 | Malfunction | Discomfort | Therapeutic or Diagnostic Output Failure, No Apparent Adverse Event |
| 2023-01-04 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Self-Activation or Keying |
| 2022-12-26 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2022-12-22 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2022-12-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Incomplete or Inadequate Connection |
| 2022-12-20 | Malfunction | Convulsion, Clonic | Therapeutic or Diagnostic Output Failure |
| 2022-12-17 | Injury | Post Operative Wound Infection, Implant Pain | Adverse Event Without Identified Device or Use Problem |
| 2022-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Failure to Interrogate, Electro-Static Discharge |
| 2022-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2022-12-09 | Injury | Dyspnea, Choking, Cough | Adverse Event Without Identified Device or Use Problem |
| 2022-12-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-12-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-25 | Injury | Decreased Appetite | Adverse Event Without Identified Device or Use Problem |
| 2022-11-22 | Malfunction | None | Failure to Sense |
| 2022-11-22 | Injury | Scar Tissue, Partial thickness (Second Degree) Burn, Full thickness (Third Degree) Burn, No Clinical Signs, Symptoms or Conditions | Self-Activation or Keying, Adverse Event Without Identified Device or Use Problem |
| 2022-11-15 | Malfunction | Cough | Inappropriate or Unexpected Reset |
| 2022-11-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-10 | Malfunction | None | Failure to Power Up |
| 2022-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, High impedance, Failure to Interrogate, Defective Component |
| 2022-10-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-25 | Malfunction | None | Failure to Deliver Energy, Physical Resistance/Sticking |
| 2022-10-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-18 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-18 | Malfunction | None | No Apparent Adverse Event, Insufficient Information |
| 2022-10-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-13 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-10 | Malfunction | None | Battery Problem |
| 2022-10-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-01 | Malfunction | None | Display or Visual Feedback Problem |
| 2022-10-01 | Malfunction | None | Failure to Power Up, Incorrect Interpretation of Signal, Failure to Sense |
| 2022-09-29 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2022-09-22 | Injury | Implant Pain | Adverse Event Without Identified Device or Use Problem |
| 2022-09-22 | Malfunction | None | Output below Specifications, No Apparent Adverse Event |
| 2022-09-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-19 | Injury | Convulsion, Clonic | None |
| 2022-09-07 | Malfunction | None | Failure to Analyze Signal |
| 2022-09-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver Energy, Low impedance, Physical Resistance/Sticking |
| 2022-09-07 | Malfunction | None | Failure to Sense |
| 2022-09-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-06 | Malfunction | None | Premature Discharge of Battery, Failure to Interrogate, Electro-Static Discharge |
| 2022-09-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-29 | Malfunction | Convulsion, Clonic | Failure to Deliver Energy, Physical Resistance/Sticking |
| 2022-08-23 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-22 | Malfunction | None | Unintended Power Up |
| 2022-08-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-16 | Malfunction | None | Premature Discharge of Battery |
| 2022-08-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-03 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-01 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2022-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-25 | Malfunction | None | Failure to Power Up |
| 2022-07-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-18 | Malfunction | None | Unexpected Shutdown |
| 2022-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-06-18 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2022-06-16 | Malfunction | None | Fracture |
| 2022-05-01 | Malfunction | None | Failure to Sense |
| 2022-04-19 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2022-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-31 | Malfunction | None | Electrical /Electronic Property Problem |
| 2022-03-24 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-11 | Malfunction | None | High impedance, Low impedance |
| 2022-03-11 | Malfunction | None | False Alarm |
| 2022-03-11 | Malfunction | None | High impedance |
| 2022-03-10 | Malfunction | None | Electrical /Electronic Property Problem |
| 2022-03-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-04 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-04 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-01 | Malfunction | None | Key or Button Unresponsive/not Working |
| 2022-03-01 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2022-03-01 | Malfunction | None | Failure to Power Up |
| 2022-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-01 | Malfunction | None | High impedance, Incomplete or Inadequate Connection |
| 2022-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-28 | Malfunction | None | Detachment of Device or Device Component |
| 2022-02-24 | Malfunction | None | Failure to Sense |
| 2022-02-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-14 | Death | None | Failure to Sense |
| 2022-02-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-05 | Injury | Convulsion, Clonic, Unspecified Heart Problem | Adverse Event Without Identified Device or Use Problem |
| 2022-02-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-28 | Malfunction | None | Fire, Arcing |
| 2021-12-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-12-01 | Injury | Status Epilepticus | Adverse Event Without Identified Device or Use Problem |
| 2021-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-10-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-09-21 | Malfunction | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2021-09-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-08-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-07-14 | Injury | Skin Infection | Adverse Event Without Identified Device or Use Problem |
| 2021-06-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-03-31 | Injury | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2021-03-31 | Death | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2021-02-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2020-12-14 | Injury | Chest Pain, Nerve Damage | Adverse Event Without Identified Device or Use Problem |
| 2020-11-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2020-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2020-10-07 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2020-08-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2020-08-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2020-05-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2020-03-06 | Injury | Discomfort | Adverse Event Without Identified Device or Use Problem |
| 2020-01-15 | Injury | Apnea | Adverse Event Without Identified Device or Use Problem |
| 2019-12-12 | Injury | Aspiration/Inhalation | Adverse Event Without Identified Device or Use Problem |
| 2019-11-19 | Malfunction | None | High impedance |
| 2019-11-03 | Malfunction | None | High impedance |
| 2019-09-18 | Malfunction | None | Energy Output Problem |
| 2019-09-08 | Death | None | Incorrect Interpretation of Signal |
| 2019-09-05 | Injury | Hiccups, Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2019-09-03 | Malfunction | None | Failure to Interrogate, Mechanical Problem |
| 2019-09-01 | Malfunction | None | Mechanical Problem, Communication or Transmission Problem |
| 2019-08-29 | Malfunction | None | High impedance |
| 2019-08-29 | Malfunction | None | High impedance |
| 2019-08-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-28 | Malfunction | None | Unintended Power Up |
| 2019-08-27 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2019-08-23 | Malfunction | None | Incorrect Interpretation of Signal |
| 2019-08-23 | Malfunction | None | Incorrect Interpretation of Signal |
| 2019-08-23 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-22 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-21 | Malfunction | None | Communication or Transmission Problem |
| 2019-08-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-19 | Malfunction | None | Computer Software Problem, Energy Output Problem |
| 2019-08-19 | Malfunction | None | High impedance |
| 2019-08-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-19 | Malfunction | None | Communication or Transmission Problem |
| 2019-08-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-17 | Malfunction | None | Computer Software Problem, Energy Output Problem |
| 2019-08-16 | Malfunction | None | Corroded |
| 2019-08-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-12 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-12 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-11 | Malfunction | None | Failure to Interrogate |
| 2019-08-11 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-09 | Malfunction | None | Failure to Interrogate, Premature End-of-Life Indicator |
| 2019-08-09 | Malfunction | None | Incorrect Interpretation of Signal |
| 2019-08-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-06 | Malfunction | None | Failure to Power Up |
| 2019-08-06 | Malfunction | None | High impedance |
| 2019-08-05 | Malfunction | None | Failure to Run on Battery |
| 2019-08-05 | Malfunction | None | Detachment of Device or Device Component |
| 2019-08-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-02 | Malfunction | None | High impedance |
| 2019-08-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-01 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2019-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-01 | Malfunction | None | Failure to Power Up |
| 2019-07-24 | Malfunction | None | High impedance |
| 2019-07-24 | Malfunction | None | High impedance |
| 2019-07-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-24 | Malfunction | None | Electrical /Electronic Property Problem, Failure to Power Up |
| 2019-07-24 | Malfunction | None | Device Sensing Problem |
| 2019-07-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-23 | Malfunction | None | Failure to Power Up |
| 2019-07-22 | Malfunction | None | Unintended Power Up |
| 2019-07-22 | Malfunction | None | High impedance |
| 2019-07-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-22 | Malfunction | None | Unexpected Shutdown |
| 2019-07-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-19 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-18 | Malfunction | None | High impedance |
| 2019-07-18 | Malfunction | None | High impedance |
| 2019-07-17 | Malfunction | None | High impedance |
| 2019-07-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-16 | Malfunction | None | Failure to Interrogate |
| 2019-07-12 | Malfunction | None | Failure to Power Up |
| 2019-07-11 | Malfunction | None | Failure to Power Up |
| 2019-07-10 | Malfunction | None | Computer Software Problem, Failure to Interrogate |
| 2019-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-07 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-03 | Malfunction | None | High impedance |
| 2019-07-03 | Malfunction | None | Energy Output Problem |
| 2019-07-01 | Malfunction | None | Failure to Sense, Device Sensing Problem |
| 2019-07-01 | Malfunction | None | Battery Problem, Device Sensing Problem |
| 2019-06-26 | Malfunction | None | High impedance |
| 2019-06-26 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-26 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-06-24 | Malfunction | None | Energy Output Problem |
| 2019-06-24 | Malfunction | None | High impedance |
| 2019-06-20 | Malfunction | None | High impedance |
| 2019-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-20 | Malfunction | None | High impedance |
| 2019-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-17 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-06-15 | Malfunction | None | High impedance |
| 2019-06-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-13 | Malfunction | None | High impedance |
| 2019-06-13 | Malfunction | None | Communication or Transmission Problem |
| 2019-06-12 | Injury | None | Gradient Increase, Obstruction of Flow |
| 2019-06-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-11 | Malfunction | None | High impedance |
| 2019-06-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-10 | Malfunction | None | Failure to Charge |
| 2019-06-07 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-07 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-06-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-04 | Malfunction | None | Failure to Power Up |
| 2019-06-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-04 | Malfunction | None | High impedance |
| 2019-06-04 | Malfunction | None | Mechanical Problem |
| 2019-06-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-03 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-06-01 | Malfunction | None | Loss of Power |
| 2019-06-01 | Malfunction | None | Unexpected Shutdown |
| 2019-06-01 | Malfunction | None | Failure to Power Up |
| 2019-06-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-01 | Malfunction | None | Failure to Power Up |
| 2019-05-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-29 | Malfunction | None | Failure to Power Up |
| 2019-05-29 | Malfunction | None | Computer Software Problem, Energy Output Problem |
| 2019-05-26 | Malfunction | None | Energy Output Problem |
| 2019-05-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-24 | Malfunction | None | Unintended Power Up |
| 2019-05-22 | Malfunction | None | Computer Software Problem, Energy Output Problem |
| 2019-05-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-19 | Death | None | Failure to Deliver Shock/Stimulation |
| 2019-05-19 | Malfunction | None | Mechanical Problem |
| 2019-05-19 | Death | None | Failure to Deliver Shock/Stimulation |
| 2019-05-17 | Malfunction | None | Power Problem |
| 2019-05-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-15 | Malfunction | None | High impedance |
| 2019-05-15 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-10 | Malfunction | None | Premature End-of-Life Indicator |
| 2019-05-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-06 | Malfunction | None | Failure to Charge, Failure to Deliver Energy |
| 2019-05-06 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-05 | Malfunction | None | Failure to Charge |
| 2019-05-05 | Malfunction | None | Failure to Power Up |
| 2019-05-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-04 | Malfunction | None | High impedance |
| 2019-05-03 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-03 | Malfunction | None | Intermittent Loss of Power |
| 2019-05-03 | Malfunction | None | High impedance |
| 2019-05-02 | Malfunction | None | Failure to Power Up |
| 2019-05-01 | Malfunction | None | High impedance |
| 2019-05-01 | Injury | Post Operative Wound Infection | Adverse Event Without Identified Device or Use Problem |
| 2019-04-25 | Malfunction | None | High impedance |
| 2019-04-24 | Malfunction | None | Premature End-of-Life Indicator |
| 2019-04-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-22 | Malfunction | None | Output Problem |
| 2019-04-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-22 | Malfunction | None | High impedance |
| 2019-04-18 | Malfunction | None | High impedance |
| 2019-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-15 | Malfunction | None | High impedance |
| 2019-04-15 | Malfunction | None | High impedance |
| 2019-04-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2019-04-14 | Malfunction | None | Unexpected Shutdown |
| 2019-04-12 | Malfunction | None | High impedance |
| 2019-04-12 | Malfunction | None | Failure to Power Up |
| 2019-04-11 | Malfunction | None | No Display/Image |
| 2019-04-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-11 | Injury | Convulsion, Clonic | Adverse Event Without Identified Device or Use Problem |
| 2019-04-10 | Malfunction | None | No Display/Image |
| 2019-04-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-10 | Malfunction | None | Failure to Interrogate |
| 2019-04-10 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-04-09 | Malfunction | None | High impedance |
| 2019-04-04 | Malfunction | None | Premature End-of-Life Indicator |
| 2019-04-04 | Malfunction | None | Unintended Power Up |
| 2019-04-03 | Malfunction | None | High impedance |
| 2019-04-03 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-03 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-03 | Malfunction | None | Connection Problem |
| 2019-04-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-03 | Malfunction | None | High impedance |
| 2019-04-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-30 | Malfunction | None | Mechanical Problem |
| 2019-03-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-29 | Malfunction | None | Connection Problem |
| 2019-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-28 | Malfunction | None | Failure to Power Up |
| 2019-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-26 | Malfunction | None | High impedance |
| 2019-03-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-19 | Malfunction | None | Insufficient Information |
| 2019-03-19 | Malfunction | None | Failure to Charge |
| 2019-03-19 | Malfunction | None | Energy Output Problem |
| 2019-03-19 | Malfunction | None | Premature End-of-Life Indicator |
| 2019-03-14 | Malfunction | None | Device Sensing Problem |
| 2019-03-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-12 | Malfunction | None | Power Problem |
| 2019-03-12 | Malfunction | None | High impedance |
| 2019-03-11 | Malfunction | None | High impedance |
| 2019-03-11 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-11 | Malfunction | None | High impedance |
| 2019-03-08 | Malfunction | None | Failure to Charge |
| 2019-03-07 | Malfunction | None | High impedance |
| 2019-03-07 | Malfunction | None | Detachment of Device or Device Component |
| 2019-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-02 | Malfunction | None | Unexpected Shutdown |
| 2019-03-01 | Malfunction | None | Unexpected Shutdown |
| 2019-02-28 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-26 | Malfunction | None | High impedance |
| 2019-02-26 | Malfunction | None | Display Difficult to Read |
| 2019-02-25 | Malfunction | None | High impedance |
| 2019-02-24 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-22 | Malfunction | None | High impedance |
| 2019-02-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-20 | Malfunction | None | Mechanical Problem |
| 2019-02-18 | Malfunction | None | High impedance |
| 2019-02-15 | Malfunction | None | Premature End-of-Life Indicator |
| 2019-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-13 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-12 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-11 | Malfunction | None | High impedance |
| 2019-02-09 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-07 | Malfunction | None | Unexpected Shutdown |
| 2019-02-06 | Malfunction | None | High impedance |
| 2019-02-06 | Malfunction | None | Failure to Power Up |
| 2019-02-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-05 | Malfunction | None | Energy Output Problem |
| 2019-02-02 | Malfunction | None | High impedance |
| 2019-02-01 | Malfunction | None | Intermittent Loss of Power |
| 2019-02-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2019-01-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-29 | Malfunction | None | Failure to Charge |
| 2019-01-26 | Malfunction | None | Computer Software Problem |
| 2019-01-25 | Malfunction | None | High impedance |
| 2019-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-24 | Malfunction | None | Connection Problem |
| 2019-01-23 | Malfunction | None | High impedance |
| 2019-01-22 | Malfunction | None | High impedance |
| 2019-01-21 | Malfunction | None | High impedance |
| 2019-01-18 | Malfunction | None | Detachment of Device or Device Component |
| 2019-01-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-14 | Malfunction | None | High impedance, Incomplete or Inadequate Connection |
| 2019-01-13 | Malfunction | None | Premature End-of-Life Indicator |
| 2019-01-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-12 | Malfunction | None | Failure to Sense |
| 2019-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-10 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-10 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-10 | Malfunction | None | Failure to Deliver Energy |
| 2019-01-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-09 | Malfunction | None | Failure to Power Up |
| 2019-01-08 | Malfunction | None | High impedance |
| 2019-01-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-08 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-08 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-01-08 | Malfunction | None | High impedance |
| 2019-01-07 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-05 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-03 | Malfunction | None | High impedance |
| 2019-01-03 | Malfunction | None | Failure to Power Up, Failure to Shut Off |
| 2019-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-01 | Malfunction | None | Energy Output Problem |
| 2018-12-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-28 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-12-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-27 | Malfunction | None | High impedance |
| 2018-12-26 | Malfunction | None | High impedance |
| 2018-12-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-21 | Malfunction | None | Insufficient Information |
| 2018-12-21 | Malfunction | None | Failure to Power Up |
| 2018-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-20 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2018-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-19 | Malfunction | None | Premature Discharge of Battery |
| 2018-12-19 | Malfunction | None | High impedance |
| 2018-12-18 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-12-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-14 | Malfunction | None | Unintended Power Up |
| 2018-12-14 | Malfunction | None | High impedance |
| 2018-12-14 | Malfunction | None | Failure to Power Up |
| 2018-12-13 | Malfunction | None | Intermittent Loss of Power |
| 2018-12-13 | Malfunction | None | Energy Output Problem |
| 2018-12-13 | Malfunction | None | High impedance |
| 2018-12-13 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2018-12-12 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-12-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-10 | Malfunction | None | Failure to Charge, Failure to Deliver Shock/Stimulation |
| 2018-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-06 | Malfunction | None | Failure to Power Up |
| 2018-12-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-05 | Malfunction | None | Connection Problem |
| 2018-12-03 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-03 | Malfunction | None | High impedance |
| 2018-12-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-12-01 | Malfunction | None | No Display/Image |
| 2018-12-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-12-01 | Malfunction | None | Failure to Power Up, Unexpected Shutdown |
| 2018-11-30 | Malfunction | None | Connection Problem |
| 2018-11-28 | Malfunction | None | Failure to Charge |
| 2018-11-21 | Malfunction | None | Detachment of Device or Device Component |
| 2018-11-21 | Malfunction | None | High impedance |
| 2018-11-20 | Malfunction | None | Mechanical Problem, Communication or Transmission Problem |
| 2018-11-20 | Malfunction | None | High impedance |
| 2018-11-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-19 | Malfunction | None | High impedance |
| 2018-11-19 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-16 | Malfunction | None | Premature End-of-Life Indicator |
| 2018-11-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2018-11-16 | Malfunction | None | No Display/Image |
| 2018-11-14 | Malfunction | None | High impedance |
| 2018-11-14 | Malfunction | None | High impedance |
| 2018-11-13 | Malfunction | None | High impedance |
| 2018-11-13 | Malfunction | None | High impedance |
| 2018-11-09 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-08 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-11-08 | Malfunction | None | Mechanical Problem |
| 2018-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-07 | Malfunction | None | High impedance |
| 2018-11-06 | Malfunction | None | High impedance |
| 2018-11-06 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-05 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2018-11-05 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-11-01 | Malfunction | None | High impedance |
| 2018-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-01 | Malfunction | None | Failure to Power Up |
| 2018-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-01 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2018-11-01 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-01 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-10-31 | Malfunction | None | High impedance |
| 2018-10-31 | Malfunction | None | High impedance |
| 2018-10-31 | Malfunction | None | High impedance |
| 2018-10-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-29 | Malfunction | None | High impedance, Detachment of Device or Device Component |
| 2018-10-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-26 | Malfunction | None | Failure to Power Up |
| 2018-10-25 | Malfunction | None | Failure to Power Up |
| 2018-10-25 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2018-10-24 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-19 | Malfunction | None | High impedance |
| 2018-10-18 | Death | None | Inappropriate or Unexpected Reset |
| 2018-10-18 | Malfunction | None | Device Sensing Problem |
| 2018-10-18 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-17 | Malfunction | None | High impedance |
| 2018-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-16 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2018-10-14 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-13 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-12 | Malfunction | None | High impedance |
| 2018-10-12 | Malfunction | None | Mechanical Problem |
| 2018-10-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-10 | Malfunction | None | Failure to Power Up |
| 2018-10-10 | Malfunction | None | High impedance |
| 2018-10-05 | Malfunction | None | Unintended Power Up |
| 2018-10-02 | Injury | None | Premature End-of-Life Indicator, Appropriate Term/Code Not Available |
| 2018-10-02 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-10-02 | Death | None | Failure to Power Up |
| 2018-10-02 | Malfunction | None | Failure to Charge |
| 2018-10-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-02 | Malfunction | None | Connection Problem |
| 2018-10-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-10-01 | Malfunction | None | No Display/Image |
| 2018-10-01 | Malfunction | None | Failure to Charge |
| 2018-10-01 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2018-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-27 | Malfunction | None | High impedance |
| 2018-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-25 | Malfunction | None | High impedance |
| 2018-09-21 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-20 | Malfunction | None | High impedance |
| 2018-09-20 | Malfunction | None | High impedance |
| 2018-09-19 | Malfunction | None | Energy Output Problem |
| 2018-09-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-17 | Malfunction | None | High impedance |
| 2018-09-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-11 | Malfunction | None | High impedance |
| 2018-09-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-10 | Malfunction | None | High impedance |
| 2018-09-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-07 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-09-07 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-07 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-05 | Malfunction | None | Premature Discharge of Battery |
| 2018-09-04 | Malfunction | None | High impedance |
| 2018-09-04 | Malfunction | None | High impedance |
| 2018-09-01 | Malfunction | None | Failure to Power Up |
| 2018-09-01 | Malfunction | None | Device Sensing Problem |
| 2018-09-01 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-09-01 | Malfunction | None | Failure to Power Up |
| 2018-08-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-31 | Malfunction | None | High impedance |
| 2018-08-31 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-30 | Malfunction | None | High impedance |
| 2018-08-30 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm, High impedance |
| 2018-08-30 | Malfunction | None | High impedance |
| 2018-08-26 | Malfunction | None | Premature Discharge of Battery |
| 2018-08-25 | Malfunction | None | Intermittent Loss of Power |
| 2018-08-23 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-08-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2018-08-22 | Malfunction | None | High impedance |
| 2018-08-21 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-21 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-08-20 | Malfunction | None | High impedance |
| 2018-08-20 | Malfunction | None | Failure to Interrogate, Mechanical Problem |
| 2018-08-17 | Malfunction | None | High impedance |
| 2018-08-16 | Malfunction | None | Premature Discharge of Battery |
| 2018-08-15 | Malfunction | None | High impedance, Difficult to Insert |
| 2018-08-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-14 | Malfunction | None | Failure to Power Up |
| 2018-08-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-08 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-07 | Malfunction | None | Communication or Transmission Problem |
| 2018-08-06 | Malfunction | None | High impedance |
| 2018-08-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-01 | Malfunction | None | Failure to Power Up |
| 2018-08-01 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-01 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-01 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-08-01 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2018-08-01 | Malfunction | None | No Display/Image |
| 2018-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-31 | Malfunction | None | High impedance |
| 2018-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-30 | Malfunction | None | Energy Output Problem |
| 2018-07-26 | Malfunction | None | High impedance |
| 2018-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-24 | Malfunction | None | Mechanical Problem |
| 2018-07-24 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-23 | Malfunction | None | Device Sensing Problem |
| 2018-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-19 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-19 | Malfunction | None | High impedance |
| 2018-07-18 | Malfunction | None | High impedance |
| 2018-07-17 | Malfunction | None | High impedance |
| 2018-07-17 | Malfunction | None | Mechanical Problem |
| 2018-07-16 | Malfunction | None | Device Sensing Problem |
| 2018-07-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-12 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-07-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-08 | Malfunction | None | Failure to Power Up |
| 2018-07-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-03 | Death | None | Connection Problem |
| 2018-07-02 | Malfunction | None | Energy Output Problem |
| 2018-07-01 | Malfunction | None | Failure to Power Up |
| 2018-07-01 | Malfunction | None | Battery Problem |
| 2018-07-01 | Malfunction | None | Display or Visual Feedback Problem |
| 2018-07-01 | Malfunction | None | Unintended Power Up |
| 2018-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-01 | Malfunction | None | No Display/Image |
| 2018-07-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-07-01 | Malfunction | None | Intermittent Loss of Power |
| 2018-07-01 | Malfunction | None | Failure to Power Up, Complete Loss of Power |
| 2018-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-01 | Malfunction | None | No Display/Image |
| 2018-06-29 | Malfunction | None | Defective Alarm, False Device Output |
| 2018-06-29 | Malfunction | None | Material Fragmentation |
| 2018-06-29 | Malfunction | None | Failure to Charge |
| 2018-06-28 | Malfunction | None | High impedance |
| 2018-06-28 | Malfunction | None | Unexpected Shutdown |
| 2018-06-28 | Malfunction | None | High impedance |
| 2018-06-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-24 | Malfunction | None | Failure to Power Up |
| 2018-06-23 | Malfunction | None | Failure to Sense |
| 2018-06-23 | Malfunction | None | Failure to Charge |
| 2018-06-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-21 | Malfunction | None | Unintended Power Up |
| 2018-06-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-18 | Malfunction | None | Premature End-of-Life Indicator |
| 2018-06-15 | Malfunction | None | High impedance |
| 2018-06-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-13 | Malfunction | None | Failure to Power Up |
| 2018-06-12 | Malfunction | None | Power Problem |
| 2018-06-11 | Malfunction | None | Failure to Deliver Energy |
| 2018-06-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-04 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-06-03 | Malfunction | None | Battery Problem |
| 2018-06-01 | Malfunction | None | Unintended Power Up, Unexpected Shutdown |
| 2018-06-01 | Malfunction | None | Failure to Run on Battery |
| 2018-06-01 | Malfunction | None | Display Difficult to Read |
| 2018-06-01 | Malfunction | None | Unexpected Shutdown |
| 2018-05-30 | Malfunction | None | Fail-Safe Design Failure, Device Operates Differently Than Expected |
| 2018-05-29 | Malfunction | None | Failure to Power Up |
| 2018-05-25 | Malfunction | None | High impedance |
| 2018-05-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-24 | Malfunction | None | No Display/Image |
| 2018-05-22 | Malfunction | None | Failure to Sense |
| 2018-05-22 | Malfunction | None | High impedance |
| 2018-05-19 | Malfunction | None | Failure To Run On AC/DC |
| 2018-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-15 | Malfunction | None | Failure to Power Up |
| 2018-05-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-14 | Injury | Dysphagia/ Odynophagia, Convulsion, Clonic, Weight Changes, Decreased Appetite | Adverse Event Without Identified Device or Use Problem |
| 2018-05-11 | Malfunction | None | Premature End-of-Life Indicator |
| 2018-05-11 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-05-10 | Injury | None | Fracture, Adverse Event Without Identified Device or Use Problem |
| 2018-05-10 | Malfunction | None | High impedance |
| 2018-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2018-05-08 | Malfunction | None | Failure to Power Up |
| 2018-05-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-07 | Malfunction | None | Failure to Charge |
| 2018-05-07 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-05-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-01 | Malfunction | None | Failure to Analyze Signal |
| 2018-05-01 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-30 | Malfunction | None | High impedance |
| 2018-04-28 | Malfunction | None | Failure To Run On AC/DC |
| 2018-04-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-19 | Malfunction | None | High impedance |
| 2018-04-18 | Malfunction | None | Energy Output To Patient Tissue Incorrect |
| 2018-04-17 | Malfunction | None | Failure To Run On AC/DC |
| 2018-04-16 | Malfunction | None | High impedance |
| 2018-04-11 | Malfunction | None | Energy Output To Patient Tissue Incorrect |
| 2018-04-09 | Malfunction | None | Device Inoperable |
| 2018-04-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-01 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-01 | Malfunction | None | Failure to Charge |
| 2018-04-01 | Malfunction | None | Power Problem |
| 2018-03-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-29 | Malfunction | None | Failure to Charge, Failure to Deliver Energy |
| 2018-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-27 | Malfunction | None | Failure to Deliver Energy |
| 2018-03-26 | Malfunction | None | Communication or Transmission Problem |
| 2018-03-26 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-26 | Malfunction | None | Detachment Of Device Component |
| 2018-03-22 | Malfunction | None | Failure to Power Up |
| 2018-03-21 | Malfunction | None | Over-Sensing |
| 2018-03-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-13 | Malfunction | None | Failure To Run On AC/DC, Unexpected Shutdown |
| 2018-03-12 | Malfunction | None | Failure to Power Up |
| 2018-03-09 | Malfunction | None | Communication or Transmission Problem |
| 2018-03-07 | Malfunction | None | No Display/Image |
| 2018-03-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-06 | Malfunction | None | No Display/Image |
| 2018-03-06 | Malfunction | None | Failure to Power Up |
| 2018-03-01 | Malfunction | None | Failure to Power Up |
| 2018-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-01 | Malfunction | None | Failure to Charge |
| 2018-02-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-26 | Malfunction | None | No Display/Image, Electrical /Electronic Property Problem |
| 2018-02-26 | Malfunction | None | High impedance |
| 2018-02-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-21 | Malfunction | None | High impedance |
| 2018-02-08 | Malfunction | None | Failure to Sense |
| 2018-02-06 | Malfunction | None | Failure to Sense |
| 2018-02-06 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-02-05 | Malfunction | None | Failure to Charge, Failure to Deliver Energy |
| 2018-02-05 | Malfunction | None | Failure to Sense |
| 2018-02-05 | Malfunction | None | Failure to Power Up |
| 2018-02-03 | Malfunction | None | Electrical /Electronic Property Problem, Device Inoperable |
| 2018-02-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-01 | Injury | None | Insufficient Information |
| 2018-02-01 | Malfunction | None | Failure to Deliver Energy |
| 2018-01-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-26 | Malfunction | None | High impedance |
| 2018-01-23 | Malfunction | None | Mechanical Problem, Low impedance, Communication or Transmission Problem |
| 2018-01-19 | Malfunction | None | Computer Software Problem |
| 2018-01-16 | Death | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-01-09 | Malfunction | None | Failure to Power Up |
| 2018-01-09 | Malfunction | None | Defibrillation/Stimulation Problem |
| 2018-01-08 | Malfunction | None | High impedance |
| 2018-01-08 | Malfunction | None | Failure To Run On AC/DC, Unexpected Shutdown |
| 2018-01-08 | Malfunction | None | Failure to Power Up |
| 2018-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-04 | Malfunction | None | Failure to Deliver Energy |
| 2018-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-03 | Malfunction | None | Failure to Power Up |
| 2018-01-02 | Malfunction | None | Failure to Power Up |
| 2018-01-01 | Malfunction | None | No Display/Image, Display or Visual Feedback Problem |
| 2018-01-01 | Malfunction | None | No Display/Image |
| 2018-01-01 | Malfunction | None | Failure to Charge |
| 2018-01-01 | Malfunction | None | Mechanical Problem, Low impedance |
| 2017-12-31 | Malfunction | None | Failure to Sense |
| 2017-12-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-21 | Malfunction | None | Failure to Charge |
| 2017-12-21 | Malfunction | None | Energy Output Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2017-12-20 | Malfunction | None | Failure to Sense |
| 2017-12-13 | Malfunction | None | High impedance |
| 2017-12-12 | Malfunction | None | Failure to Power Up |
| 2017-12-12 | Malfunction | None | High impedance |
| 2017-12-12 | Malfunction | None | Energy Output Problem, Communication or Transmission Problem |
| 2017-12-08 | Malfunction | None | Failure to Power Up |
| 2017-12-08 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-12-08 | Malfunction | None | Use of Device Problem, Device Handling Problem |
| 2017-12-07 | Malfunction | None | Failure to Charge |
| 2017-12-05 | Malfunction | None | No Display/Image |
| 2017-12-04 | Malfunction | None | No Display/Image |
| 2017-12-01 | Malfunction | None | High impedance |
| 2017-12-01 | Injury | None | Device Displays Incorrect Message, Battery Problem |
| 2017-12-01 | Malfunction | None | Premature End-of-Life Indicator |
| 2017-12-01 | Malfunction | None | No Display/Image |
| 2017-11-30 | Malfunction | None | Unintended Power Up |
| 2017-11-30 | Malfunction | None | No Display/Image |
| 2017-11-30 | Malfunction | None | Failure to Power Up |
| 2017-11-28 | Malfunction | None | Device Inoperable |
| 2017-11-27 | Malfunction | None | Failure to Power Up |
| 2017-11-20 | Malfunction | None | Failure To Run On AC/DC |
| 2017-11-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-16 | Malfunction | None | Display or Visual Feedback Problem |
| 2017-11-15 | Malfunction | None | Fracture |
| 2017-11-14 | Malfunction | None | Failure to Power Up |
| 2017-11-10 | Malfunction | None | Failure to Charge, Failure to Deliver Energy |
| 2017-11-06 | Malfunction | None | Unintended Power Up |
| 2017-11-02 | Malfunction | None | Failure to Power Up |
| 2017-10-25 | Malfunction | None | Failure to Charge |
| 2017-10-24 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-22 | Malfunction | None | Power Problem |
| 2017-10-18 | Malfunction | None | Failure to Power Up |
| 2017-10-18 | Malfunction | None | High impedance |
| 2017-10-18 | Malfunction | None | Failure to Sense |
| 2017-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-17 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Device Inoperable, Device Displays Incorrect Message |
| 2017-10-16 | Malfunction | None | Failure to Power Up |
| 2017-10-16 | Malfunction | None | Incorrect Interpretation of Signal |
| 2017-10-13 | Malfunction | None | Failure to Power Up |
| 2017-10-13 | Malfunction | None | Power Problem |
| 2017-10-13 | Malfunction | None | No Display/Image |
| 2017-10-03 | Malfunction | None | Failure to Power Up |
| 2017-10-03 | Malfunction | None | Failure to Power Up |
| 2017-10-01 | Injury | None | Insufficient Information |
| 2017-09-29 | Malfunction | None | Unintended Power Up |
| 2017-09-29 | Malfunction | None | Failure to Deliver Energy |
| 2017-09-26 | Malfunction | None | Failure to Power Up |
| 2017-09-25 | Malfunction | None | Display or Visual Feedback Problem |
| 2017-09-25 | Injury | None | Insufficient Information |
| 2017-09-20 | Malfunction | None | Failure to Power Up |
| 2017-09-07 | Malfunction | None | Display or Visual Feedback Problem |
| 2017-09-05 | Malfunction | None | Unintended Power Up |
| 2017-08-30 | Malfunction | None | Failure to Power Up |
| 2017-08-30 | Malfunction | None | Premature Discharge of Battery |
| 2017-08-30 | Malfunction | None | Premature Discharge of Battery |
| 2017-08-24 | Malfunction | None | Unintended Power Up, Device Inoperable |
| 2017-08-21 | Injury | None | Insufficient Information |
| 2017-08-14 | Malfunction | None | Failure to Power Up, Device Displays Incorrect Message |
| 2017-08-09 | Malfunction | None | Failure To Run On AC/DC |
| 2017-08-08 | Malfunction | None | Failure To Run On AC/DC |
| 2017-08-08 | Malfunction | None | No Display/Image |
| 2017-08-03 | Malfunction | None | Failure To Run On AC/DC |
| 2017-07-28 | Malfunction | None | Failure to Deliver Shock/Stimulation |
| 2017-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-26 | Malfunction | None | Failure to Power Up |
| 2017-07-20 | Malfunction | None | Defibrillation/Stimulation Problem, Device Displays Incorrect Message |
| 2017-07-17 | Malfunction | None | Failure to Deliver Energy |
| 2017-07-12 | Malfunction | None | Failure To Run On AC/DC |
| 2017-07-11 | Malfunction | None | Premature Discharge of Battery, Failure to Power Up |
| 2017-07-07 | Death | None | Failure to Deliver Energy |
| 2017-07-06 | Malfunction | None | No Display/Image |
| 2017-07-04 | Injury | None | Insufficient Information |
| 2017-06-27 | Malfunction | None | Power Problem |
| 2017-06-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-26 | Injury | None | Gradient Increase |
| 2017-06-26 | Malfunction | None | Unintended Power Up |
| 2017-06-21 | Malfunction | None | Failure to Power Up |
| 2017-06-16 | Injury | None | Device Operates Differently Than Expected, Insufficient Information |
| 2017-06-11 | Malfunction | None | Failure to Analyze Signal, Defibrillation/Stimulation Problem |
| 2017-06-07 | Malfunction | None | Failure to Charge, Device Displays Incorrect Message |
| 2017-06-06 | Malfunction | None | Failure to Power Up |
| 2017-05-29 | Malfunction | None | Device Displays Incorrect Message |
| 2017-05-29 | Malfunction | None | Failure To Run On AC/DC, Device Displays Incorrect Message |
| 2017-05-23 | Malfunction | None | Failure to Deliver Energy |
| 2017-05-17 | Malfunction | None | Failure to Deliver Energy, Device Displays Incorrect Message |
| 2017-05-15 | Malfunction | None | Self-Activation or Keying |
| 2017-05-11 | Death | None | Failure to Run on Battery, Device Operates Differently Than Expected |
| 2017-05-10 | Malfunction | None | Failure to Power Up |
| 2017-05-10 | Malfunction | None | Unintended Power Up |
| 2017-04-26 | Injury | None | Insufficient Information |
| 2017-04-20 | Malfunction | None | Defibrillation/Stimulation Problem, Device Displays Incorrect Message |
| 2017-04-19 | Malfunction | None | Defibrillation/Stimulation Problem, Device Displays Incorrect Message |
| 2017-04-05 | Injury | None | Gradient Increase |
| 2017-04-03 | Malfunction | None | Failure to Power Up |
| 2017-03-29 | Death | None | Failure To Run On AC/DC |
| 2017-03-28 | Malfunction | None | Power Problem |
| 2017-03-24 | Malfunction | None | Defibrillation/Stimulation Problem |
| 2017-03-20 | Malfunction | None | Bent |
| 2017-03-15 | Malfunction | None | Power Problem |
| 2017-03-14 | Malfunction | None | Defibrillation/Stimulation Problem, Device Displays Incorrect Message |
| 2017-03-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-08 | Malfunction | None | Energy Output Problem |
| 2017-03-06 | Malfunction | None | Failure to Power Up |
| 2017-03-06 | Death | None | Failure to Sense |
| 2017-03-01 | Malfunction | None | Device Sensing Problem |
| 2017-02-27 | Malfunction | None | Power Problem |
| 2017-02-24 | Malfunction | None | Failure to Sense |
| 2017-02-21 | Malfunction | None | Failure to Power Up |
| 2017-02-21 | Malfunction | None | Device Inoperable |
| 2017-02-21 | Malfunction | None | Unintended Power Up |
| 2017-02-16 | Malfunction | None | Failure to Power Up |
| 2017-02-15 | Malfunction | None | No Display/Image |
| 2017-02-15 | Malfunction | None | Failure to Deliver Energy |
| 2017-02-14 | Malfunction | None | Unintended Power Up |
| 2017-02-13 | Malfunction | None | Battery Problem |
| 2017-02-10 | Malfunction | None | No Display/Image |
| 2017-02-08 | Malfunction | None | Failure to Power Up |
| 2017-01-30 | Malfunction | None | Defibrillation/Stimulation Problem |
| 2017-01-27 | Malfunction | None | Power Problem |
| 2017-01-27 | Malfunction | None | Power Problem |
| 2017-01-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-09 | Malfunction | None | Failure to Power Up |
| 2017-01-06 | Malfunction | None | Failure to Power Up |
| 2017-01-05 | Injury | None | Insufficient Information |
| 2017-01-03 | Malfunction | None | Device Sensing Problem |
| 2017-01-03 | Malfunction | None | Device Inoperable |
| 2017-01-01 | Malfunction | None | Failure to Interrogate, Device Remains Activated |
| 2017-01-01 | Injury | None | Insufficient Information |
| 2016-12-26 | Malfunction | None | Power Problem |
| 2016-12-21 | Malfunction | None | Failure to Power Up |
| 2016-12-18 | Malfunction | None | No Display/Image |
| 2016-12-17 | Malfunction | None | Power Problem |
| 2016-12-16 | Death | None | Failure to Analyze Signal |
| 2016-12-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-01 | Malfunction | None | Failure to Sense |
| 2016-11-29 | Malfunction | None | Failure to Power Up |
| 2016-11-24 | Malfunction | None | Failure to Power Up |
| 2016-11-21 | Malfunction | None | Failure to Power Up |
| 2016-11-21 | Malfunction | None | Connection Problem |
| 2016-11-09 | Malfunction | None | Failure to Power Up |
| 2016-11-08 | Malfunction | None | Failure to Power Up |
| 2016-11-07 | Malfunction | None | Failure to Deliver Energy, Device Displays Incorrect Message |
| 2016-11-07 | Malfunction | None | Failure to Charge, Failure to Deliver Energy, Device Displays Incorrect Message |
| 2016-11-02 | Malfunction | None | Failure to Power Up |
| 2016-10-21 | Malfunction | None | Device Displays Incorrect Message |
| 2016-10-21 | Malfunction | None | Premature Discharge of Battery |
| 2016-10-20 | Malfunction | None | Defibrillation/Stimulation Problem, Device Displays Incorrect Message |
| 2016-10-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-10 | Malfunction | None | Failure to Power Up |
| 2016-10-07 | Malfunction | None | No Display/Image |
| 2016-10-07 | Malfunction | None | Failure to Power Up |
| 2016-10-05 | Malfunction | None | Failure to Power Up |
| 2016-10-05 | Malfunction | None | Failure to Sense |
| 2016-10-04 | Malfunction | None | Failure to Power Up |
| 2016-10-03 | Malfunction | None | Failure to Charge |
| 2016-10-02 | Malfunction | None | Connection Problem |
| 2016-09-19 | Malfunction | None | Failure to Power Up |
| 2016-09-08 | Malfunction | None | Failure to Power Up |
| 2016-09-07 | Malfunction | None | Failure to Power Up |
| 2016-09-01 | Malfunction | None | Defibrillation/Stimulation Problem |
| 2016-08-30 | Malfunction | None | No Display/Image, Device Inoperable |
| 2016-08-29 | Malfunction | None | Failure to Power Up |
| 2016-08-25 | Malfunction | None | Device Inoperable |
| 2016-08-24 | Malfunction | None | Power Problem |
| 2016-08-23 | Malfunction | None | Power Problem |
| 2016-08-22 | Malfunction | None | Device Inoperable |
| 2016-08-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-18 | Death | None | Failure To Run On AC/DC, Power Problem |
| 2016-08-17 | Malfunction | None | Unintended Power Up |
| 2016-08-08 | Malfunction | None | Failure to Power Up |
| 2016-08-02 | Malfunction | None | Power Problem |
| 2016-07-25 | Malfunction | None | Self-Activation or Keying |
| 2016-07-21 | Malfunction | None | Unintended Power Up |
| 2016-07-18 | Malfunction | None | Device Inoperable |
| 2016-06-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-29 | Malfunction | None | Connection Problem |
| 2016-06-20 | Malfunction | None | Failure to Power Up |
| 2016-06-12 | Malfunction | None | Defibrillation/Stimulation Problem |
| 2016-06-07 | Malfunction | None | Defibrillation/Stimulation Problem, Device Displays Incorrect Message |
| 2016-04-01 | Malfunction | None | Power Problem |
| 2015-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-09-23 | Malfunction | None | Failure to Sense |
| 2015-05-09 | Malfunction | None | Failure to Sense |
| 2015-05-07 | Malfunction | None | Failure to Power Up |
| 2015-04-28 | Malfunction | None | Failure to Power Up |
| 2015-04-26 | Malfunction | None | Failure to Power Up |
| 2015-04-26 | Death | None | Incorrect Interpretation of Signal, Use of Device Problem |
| 2015-04-20 | Malfunction | None | Image Display Error/Artifact |
| 2015-04-15 | Malfunction | None | Failure to Power Up |
| 2015-04-15 | Malfunction | None | Connection Problem |
| 2015-04-09 | Malfunction | None | Failure to Power Up |
| 2015-03-31 | Malfunction | None | Device Inoperable |
| 2015-03-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-03-26 | Malfunction | None | Device Inoperable |
| 2015-03-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-03-09 | Malfunction | None | Defibrillation/Stimulation Problem, Device Displays Incorrect Message |
| 2015-02-13 | Malfunction | None | Failure to Power Up |
| 2014-12-18 | Malfunction | None | Failure to Power Up |
| 2014-07-17 | Malfunction | None | Failure to Power Up |
| 2014-07-15 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-07-11 | Malfunction | None | Failure to Power Up |
| 2014-07-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-07-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-07-10 | Malfunction | None | Failure to Power Up |
| 2014-07-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-07-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-07-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-07-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-07-06 | Malfunction | None | Power Problem |
| 2014-07-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-27 | Malfunction | None | Device Sensing Problem |
| 2014-06-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-20 | Malfunction | None | No Display/Image |
| 2014-06-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-13 | Malfunction | None | Failure to Power Up |
| 2014-06-13 | Malfunction | None | Failure to Power Up |
| 2014-06-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-03 | Malfunction | None | No Display/Image |
| 2014-06-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-02 | Malfunction | None | Failure to Power Up |
| 2014-06-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-05-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-05-29 | Malfunction | None | Failure to Power Up |
| 2014-05-25 | Malfunction | None | Device Inoperable |
| 2014-05-22 | Malfunction | None | Failure to Deliver Energy |
| 2014-05-19 | Malfunction | None | Power Problem |
| 2014-05-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-05-19 | Malfunction | None | Failure to Power Up |
| 2014-05-10 | Malfunction | None | Failure To Run On AC/DC |
| 2014-05-09 | Malfunction | None | Failure to Power Up, Device Displays Incorrect Message |
| 2014-04-30 | Death | None | Use of Device Problem |
| 2014-04-22 | Malfunction | None | Device Inoperable |
| 2014-04-18 | Malfunction | None | Failure to Power Up |
| 2014-04-16 | Malfunction | None | Invalid Sensing |
| 2014-04-15 | Malfunction | None | Power Problem |
| 2014-04-14 | Malfunction | None | No Display/Image, Failure to Deliver Energy |
| 2014-04-14 | Malfunction | None | Power Problem |
| 2014-04-09 | Death | None | Failure To Run On AC/DC |
| 2014-04-07 | Malfunction | None | Power Problem |
| 2014-04-07 | Malfunction | None | Failure to Sense, Device Displays Incorrect Message |
| 2014-04-03 | Malfunction | None | Failure to Power Up |
| 2014-03-31 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Device Displays Incorrect Message |
| 2014-03-19 | Malfunction | None | Power Problem |
| 2014-03-18 | Injury | None | Detachment Of Device Component, Device Inoperable |
| 2014-03-18 | Death | None | Improper or Incorrect Procedure or Method |
| 2014-03-04 | Malfunction | None | Failure to Power Up |
| 2014-02-28 | Injury | None | Perivalvular Leak, Torn Material |
| 2014-02-24 | Malfunction | None | Failure to Power Up |
| 2014-02-18 | Malfunction | None | Power Problem |
| 2014-02-14 | Malfunction | None | Device Inoperable |
| 2014-02-12 | Malfunction | None | Incorrect Interpretation of Signal |
| 2014-02-07 | Malfunction | None | Power Problem |
| 2014-02-05 | Malfunction | None | Device Inoperable, Invalid Sensing |
| 2014-01-27 | Malfunction | None | No Display/Image |
| 2014-01-27 | Malfunction | None | Power Problem |
| 2014-01-14 | Malfunction | None | Failure to Power Up |
| 2014-01-13 | Injury | None | Device Operates Differently Than Expected |
| 2014-01-09 | Malfunction | None | Failure To Run On AC/DC |
| 2014-01-07 | Malfunction | None | Failure to Charge |
| 2014-01-02 | Malfunction | None | Failure to Deliver Energy |
| 2013-12-22 | Malfunction | None | Connection Problem |
| 2013-12-21 | Death | None | Connection Problem |
| 2013-12-12 | Malfunction | None | Failure to Power Up |
| 2013-12-12 | Malfunction | None | Failure To Run On AC/DC |
| 2013-12-08 | Malfunction | None | Failure To Run On AC/DC |
| 2013-12-05 | Malfunction | None | None |
| 2013-11-29 | Malfunction | None | None |
| 2013-11-27 | Malfunction | None | None |
| 2013-11-23 | Malfunction | None | Failure to Power Up |
| 2013-11-22 | Death | None | None |
| 2013-11-21 | Malfunction | None | None |
| 2013-11-21 | Malfunction | None | Failure To Run On AC/DC |
| 2013-11-20 | Death | None | Defibrillation/Stimulation Problem |
| 2013-11-12 | Malfunction | None | None |
| 2013-11-08 | Death | None | None |
| 2013-11-07 | Malfunction | None | Premature Discharge of Battery |
| 2013-11-04 | Malfunction | None | None |
| 2013-11-03 | Death | None | None |
| 2013-10-29 | Malfunction | None | None |
| 2013-10-24 | Malfunction | None | Failure to Auto Stop |
| 2013-10-22 | Malfunction | None | None |
| 2013-10-21 | Malfunction | None | None |
| 2013-10-16 | Death | None | None |
| 2013-10-16 | Death | None | None |
| 2013-10-12 | Malfunction | None | None |
| 2013-10-04 | Malfunction | None | None |
| 2013-09-30 | Malfunction | None | None |
| 2013-09-24 | Malfunction | None | None |
| 2013-09-24 | Malfunction | None | None |
| 2013-09-22 | Malfunction | None | None |
| 2013-09-19 | Malfunction | None | None |
| 2013-09-17 | Malfunction | None | None |
| 2013-09-16 | Malfunction | None | None |
| 2013-09-16 | Malfunction | None | None |
| 2013-09-12 | Malfunction | None | None |
| 2013-09-09 | Malfunction | None | None |
| 2013-09-04 | Malfunction | None | None |
| 2013-08-29 | Malfunction | None | None |
| 2013-08-20 | Malfunction | None | None |
| 2013-08-18 | Death | None | None |
| 2013-08-14 | Malfunction | None | None |
| 2013-08-12 | Malfunction | None | None |
| 2013-08-07 | Malfunction | None | None |
| 2013-08-02 | Malfunction | None | None |
| 2013-07-28 | Malfunction | None | None |
| 2013-07-16 | Death | None | None |
| 2013-07-15 | Malfunction | None | None |
| 2013-07-15 | Malfunction | None | None |
| 2013-07-15 | Malfunction | None | None |
| 2013-07-09 | Malfunction | None | None |
| 2013-06-28 | Malfunction | None | None |
| 2013-06-28 | Malfunction | None | None |
| 2013-06-25 | Malfunction | None | None |
| 2013-06-19 | Malfunction | None | None |
| 2013-06-18 | Malfunction | None | Power Problem |
| 2013-06-14 | Malfunction | None | None |
| 2013-06-12 | Injury | None | None |
| 2013-06-12 | Malfunction | None | None |
| 2013-06-07 | Malfunction | None | None |
| 2013-05-29 | Malfunction | None | None |
| 2013-05-24 | Malfunction | None | None |
| 2013-05-16 | Malfunction | None | None |
| 2013-05-16 | Malfunction | None | None |
| 2013-05-14 | Malfunction | None | None |
| 2013-05-07 | Malfunction | None | None |
| 2013-05-06 | Malfunction | None | None |
| 2013-05-03 | Malfunction | None | None |
| 2013-05-03 | Malfunction | None | None |
| 2013-05-01 | Injury | None | None |
| 2013-04-27 | Malfunction | None | None |
| 2013-04-24 | Malfunction | None | None |
| 2013-04-08 | Malfunction | None | None |
| 2013-03-29 | Malfunction | None | None |
| 2013-03-28 | Malfunction | None | None |
| 2013-03-24 | Malfunction | None | None |
| 2013-03-18 | Injury | None | None |
| 2013-03-06 | Malfunction | None | None |
| 2013-03-04 | Malfunction | None | None |
| 2013-03-04 | Malfunction | None | None |
| 2013-02-27 | Malfunction | None | None |
| 2013-02-25 | Malfunction | None | None |
| 2013-02-25 | Malfunction | None | None |
| 2013-02-21 | Malfunction | None | None |
| 2013-02-08 | Malfunction | None | None |
| 2013-02-07 | Malfunction | None | None |
| 2013-02-07 | Malfunction | None | None |
| 2013-02-06 | Injury | None | None |
| 2013-02-05 | Malfunction | None | None |
| 2013-02-01 | Malfunction | None | None |
| 2013-01-28 | Malfunction | None | None |
| 2013-01-28 | Malfunction | None | Power Problem |
| 2013-01-22 | Malfunction | None | None |
| 2013-01-22 | Malfunction | None | None |
| 2013-01-16 | Malfunction | None | None |
| 2013-01-11 | Malfunction | None | None |
| 2013-01-09 | Malfunction | None | None |
| 2013-01-07 | Other | None | None |
| 2013-01-03 | Malfunction | None | None |
| 2013-01-02 | Malfunction | None | None |
| 2013-01-02 | Malfunction | None | None |
| 2012-12-10 | Malfunction | None | None |
| 2012-12-04 | Malfunction | None | None |
| 2012-12-03 | Malfunction | None | None |
| 2012-11-30 | Malfunction | None | Failure To Run On AC/DC |
| 2012-11-29 | Malfunction | None | None |
| 2012-11-14 | Malfunction | None | None |
| 2012-11-14 | Injury | None | None |
| 2012-11-08 | Malfunction | None | None |
| 2012-11-05 | Malfunction | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-10-31 | Malfunction | None | None |
| 2012-10-26 | Malfunction | None | None |
| 2012-10-17 | Malfunction | None | None |
| 2012-10-15 | Malfunction | None | None |
| 2012-10-12 | Malfunction | None | None |
| 2012-10-11 | Malfunction | None | None |
| 2012-10-01 | Malfunction | None | None |
| 2012-09-28 | Malfunction | None | None |
| 2012-09-28 | Malfunction | None | Power Problem |
| 2012-09-25 | Malfunction | None | None |
| 2012-09-25 | Malfunction | None | None |
| 2012-09-12 | Malfunction | None | None |
| 2012-09-12 | Malfunction | None | None |
| 2012-09-10 | Malfunction | None | None |
| 2012-08-30 | Malfunction | None | None |
| 2012-08-29 | Malfunction | None | None |
| 2012-08-22 | Malfunction | None | None |
| 2012-08-20 | Injury | None | None |
| 2012-08-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-08-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-08-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-08-13 | Malfunction | None | None |
| 2012-08-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-08-09 | Malfunction | None | None |
| 2012-08-01 | Injury | None | None |
| 2012-08-01 | Malfunction | None | None |
| 2012-07-31 | Malfunction | None | None |
| 2012-07-17 | Malfunction | None | None |
| 2012-07-11 | Malfunction | None | None |
| 2012-07-04 | Injury | None | None |
| 2012-06-28 | Malfunction | None | None |
| 2012-06-11 | Malfunction | None | None |
| 2012-06-06 | Malfunction | None | None |
| 2012-05-30 | Malfunction | None | None |
| 2012-05-22 | Malfunction | None | None |
| 2012-05-16 | Malfunction | None | None |
| 2012-05-15 | Malfunction | None | None |
| 2012-05-15 | Malfunction | None | None |
| 2012-05-10 | Malfunction | None | None |
| 2012-05-09 | Injury | None | None |
| 2012-05-05 | Malfunction | None | None |
| 2012-05-03 | Malfunction | None | None |
| 2012-05-01 | Injury | None | None |
| 2012-04-25 | Malfunction | None | None |
| 2012-04-18 | Injury | None | None |
| 2012-04-14 | Death | None | None |
| 2012-04-13 | Malfunction | None | None |
| 2012-04-13 | Malfunction | None | None |
| 2012-04-13 | Malfunction | None | None |
| 2012-04-13 | Malfunction | None | None |
| 2012-04-13 | Malfunction | None | None |
| 2012-04-02 | Malfunction | None | None |
| 2012-03-23 | Malfunction | None | None |
| 2012-03-22 | Malfunction | None | None |
| 2012-03-19 | Malfunction | None | None |
| 2012-03-09 | Malfunction | None | None |
| 2012-03-07 | Malfunction | None | None |
| 2012-02-17 | Malfunction | None | None |
| 2012-02-16 | Malfunction | None | None |
| 2012-02-14 | Malfunction | None | None |
| 2012-02-14 | Malfunction | None | None |
| 2012-02-07 | Malfunction | None | None |
| 2012-01-29 | Malfunction | None | None |
| 2012-01-27 | Malfunction | None | None |
| 2012-01-24 | Malfunction | None | None |
| 2012-01-23 | Malfunction | None | None |
| 2012-01-12 | Malfunction | None | None |
| 2012-01-09 | Malfunction | None | None |
| 2012-01-03 | Malfunction | None | None |
| 2011-12-22 | Malfunction | None | None |
| 2011-12-20 | Malfunction | None | None |
| 2011-12-10 | Malfunction | None | None |
| 2011-12-09 | Malfunction | None | None |
| 2011-11-12 | Death | None | None |
| 2011-11-09 | Malfunction | None | None |
| 2011-11-02 | Malfunction | None | None |
| 2011-11-02 | Malfunction | None | None |
| 2011-11-01 | Malfunction | None | None |
| 2011-10-21 | Malfunction | None | None |
| 2011-10-07 | Malfunction | None | Power Problem |
| 2011-10-04 | Malfunction | None | None |
| 2011-10-03 | Malfunction | None | None |
| 2011-10-02 | Malfunction | None | None |
| 2011-09-28 | Malfunction | None | None |
| 2011-09-06 | Injury | None | None |
| 2011-09-01 | Other | None | None |
| 2011-08-22 | Injury | None | None |
| 2011-08-17 | Death | None | None |
| 2011-08-12 | Injury | None | None |
| 2011-08-01 | Malfunction | None | None |
| 2011-07-29 | Injury | None | None |
| 2011-07-28 | Malfunction | None | None |
| 2011-07-26 | Malfunction | None | None |
| 2011-07-19 | Injury | None | None |
| 2011-07-18 | Injury | None | None |
| 2011-07-18 | Malfunction | None | None |
| 2011-07-08 | Malfunction | None | None |
| 2011-07-07 | Malfunction | None | None |
| 2011-07-07 | Malfunction | None | None |
| 2011-07-07 | Malfunction | None | None |
| 2011-06-15 | Malfunction | None | None |
| 2011-06-14 | Malfunction | None | None |
| 2011-06-08 | Malfunction | None | None |
| 2011-06-07 | Malfunction | None | None |
| 2011-06-07 | Malfunction | None | None |
| 2011-05-27 | Malfunction | None | None |
| 2011-05-23 | Injury | None | None |
| 2011-05-13 | Malfunction | None | None |
| 2011-05-10 | Malfunction | None | None |
| 2011-05-10 | Malfunction | None | None |
| 2011-05-10 | Malfunction | None | None |
| 2011-05-06 | Malfunction | None | None |
| 2011-05-06 | Malfunction | None | None |
| 2011-05-05 | Malfunction | None | None |
| 2011-04-22 | Malfunction | None | None |
| 2011-04-20 | Malfunction | None | None |
| 2011-04-20 | Malfunction | None | None |
| 2011-04-18 | Malfunction | None | None |
| 2011-04-11 | Malfunction | None | None |
| 2011-04-06 | Malfunction | None | None |
| 2011-03-28 | Malfunction | None | None |
| 2011-03-25 | Injury | None | None |
| 2011-03-08 | Malfunction | None | None |
| 2011-03-03 | Injury | None | None |
| 2011-02-25 | Malfunction | None | None |
| 2011-02-18 | Malfunction | None | None |
| 2011-02-16 | Injury | None | None |
| 2011-02-09 | Injury | None | None |
| 2011-02-08 | Malfunction | None | Power Problem |
| 2011-02-03 | Malfunction | None | None |
| 2011-01-28 | Malfunction | None | None |
| 2011-01-24 | Malfunction | None | None |
| 2011-01-11 | Malfunction | None | None |
| 2011-01-10 | Malfunction | None | None |
| 2011-01-05 | Malfunction | None | None |
| 2011-01-05 | Malfunction | None | None |
| 2010-12-29 | Malfunction | None | None |
| 2010-12-23 | Malfunction | None | None |
| 2010-12-15 | Malfunction | None | None |
| 2010-12-08 | Malfunction | None | None |
| 2010-12-02 | Malfunction | None | None |
| 2010-11-30 | Death | None | None |
| 2010-11-24 | Malfunction | None | None |
| 2010-11-24 | Malfunction | None | None |
| 2010-11-09 | Malfunction | None | None |
| 2010-10-29 | Injury | None | None |
| 2010-10-20 | Malfunction | None | None |
| 2010-10-20 | Malfunction | None | None |
| 2010-10-20 | Malfunction | None | None |
| 2010-10-18 | Malfunction | None | None |
| 2010-10-15 | Malfunction | None | None |
| 2010-09-30 | Malfunction | None | None |
| 2010-09-29 | Malfunction | None | None |
| 2010-09-27 | Malfunction | None | None |
| 2010-09-23 | Malfunction | None | None |
| 2010-09-21 | Malfunction | None | None |
| 2010-09-21 | Malfunction | None | None |
| 2010-09-20 | Malfunction | None | None |
| 2010-09-14 | Injury | None | None |
| 2010-09-14 | Malfunction | None | None |
| 2010-09-13 | Malfunction | None | None |
| 2010-09-09 | Malfunction | None | None |
| 2010-09-07 | Malfunction | None | None |
| 2010-09-07 | Malfunction | None | None |
| 2010-09-04 | Malfunction | None | None |
| 2010-09-01 | Malfunction | None | None |
| 2010-08-30 | Malfunction | None | None |
| 2010-08-18 | Malfunction | None | None |
| 2010-08-06 | Malfunction | None | None |
| 2010-08-05 | Malfunction | None | None |
| 2010-08-05 | Malfunction | None | None |
| 2010-08-04 | Malfunction | None | None |
| 2010-08-02 | Other | None | None |
| 2010-07-22 | Malfunction | None | None |
| 2010-07-13 | Malfunction | None | None |
| 2010-07-06 | Malfunction | None | None |
| 2010-07-02 | Malfunction | None | None |
| 2010-06-28 | Malfunction | None | None |
| 2010-06-18 | Malfunction | None | None |
| 2010-06-15 | Injury | None | None |
| 2010-06-15 | Malfunction | None | None |
| 2010-06-11 | Malfunction | None | None |
| 2010-06-11 | Malfunction | None | None |
| 2010-06-10 | Malfunction | None | None |
| 2010-05-26 | Malfunction | None | None |
| 2010-05-24 | Malfunction | None | None |
| 2010-05-24 | Other | None | None |
| 2010-05-10 | Malfunction | None | None |
| 2010-05-05 | Other | None | None |
| 2010-05-03 | Malfunction | None | None |
| 2010-04-27 | Malfunction | None | None |
| 2010-04-19 | Malfunction | None | None |
| 2010-04-08 | Malfunction | None | None |
| 2010-04-01 | Other | None | None |
| 2010-03-26 | Malfunction | None | None |
| 2010-03-25 | Other | None | None |
| 2010-03-22 | Other | None | None |
| 2010-03-19 | Other | None | None |
| 2010-03-18 | Other | None | None |
| 2010-03-16 | Injury | None | None |
| 2010-03-08 | Malfunction | None | None |
| 2010-03-08 | Other | None | None |
| 2010-03-04 | Other | None | None |
| 2010-03-04 | Malfunction | None | None |
| 2010-03-03 | Malfunction | None | None |
| 2010-03-01 | Malfunction | None | None |
| 2010-03-01 | Malfunction | None | None |
| 2010-03-01 | Malfunction | None | None |
| 2010-02-27 | Death | None | None |
| 2010-02-27 | Malfunction | None | None |
| 2010-02-22 | Other | None | None |
| 2010-02-19 | Malfunction | None | Failure To Run On AC/DC |
| 2010-02-18 | Malfunction | None | None |
| 2010-02-14 | Malfunction | None | None |
| 2010-02-09 | Malfunction | None | None |
| 2010-02-04 | Death | None | None |
| 2010-01-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2010-01-18 | Malfunction | None | None |
| 2010-01-01 | Other | None | None |
| 2009-12-28 | Malfunction | None | Power Problem |
| 2009-12-08 | Malfunction | None | None |
| 2009-12-07 | Malfunction | None | None |
| 2009-11-17 | Malfunction | None | Power Problem |
| 2009-11-05 | Malfunction | None | None |