IMPLANTABLE PACING LEAD
This device is manufactured by MEDTRONIC, MEDTRONIC EP SYSTEMS, MEDTRONIC IRELAND, MEDTRONIC PLC, MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO OPERATIONS CO, MEDTRONIC SINGAPORE OPERATIONS, RICE CREEK MANUFACTURING, RICE CREEK MFG.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-23 | Malfunction | Tachycardia | None |
| 2024-07-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing, Pacing Problem |
| 2024-06-03 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-05-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2024-05-15 | Injury | Unspecified Infection, Pocket Erosion | None |
| 2024-05-08 | Injury | No Clinical Signs, Symptoms or Conditions | Fracture |
| 2024-04-23 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Decreased Sensitivity, Impedance Problem |
| 2024-04-23 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-08 | Malfunction | Dizziness | Signal Artifact/Noise, Device Dislodged or Dislocated |
| 2024-04-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2024-03-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Mechanical Problem |
| 2024-03-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-29 | Injury | Pneumothorax, Heart Failure/Congestive Heart Failure | None |
| 2024-02-23 | Malfunction | Appropriate Term / Code Not Available | Appropriate Term/Code Not Available |
| 2024-02-19 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-07 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-02-07 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2024-01-18 | Injury | Unspecified Infection | None |
| 2024-01-18 | Injury | Unspecified Infection | None |
| 2024-01-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-01-10 | Injury | Undesired Nerve Stimulation | Intermittent Capture, Adverse Event Without Identified Device or Use Problem |
| 2024-01-03 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Fracture, High impedance, Over-Sensing, Impedance Problem, High Capture Threshold |
| 2023-12-15 | Injury | No Clinical Signs, Symptoms or Conditions | Fracture |
| 2023-11-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Under-Sensing, Decreased Sensitivity, Capturing Problem |
| 2023-11-14 | Injury | Cardiac Arrest, Endocarditis, Unspecified Infection, Undesired Nerve Stimulation, Pneumothorax, Cardiac Tamponade, Vascular Dissection, Thrombosis/Thrombus | None |
| 2023-11-14 | Death | Insufficient Information | None |
| 2023-11-13 | Injury | Unspecified Infection, Perforation, Pneumothorax, Shock from Patient Lead(s), Thrombosis/Thrombus | Inappropriate/Inadequate Shock/Stimulation, Adverse Event Without Identified Device or Use Problem |
| 2023-11-08 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-10-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Low impedance |
| 2023-10-24 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-10-20 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-20 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-20 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-20 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-16 | Death | Cardiac Arrest, Tachycardia | Under-Sensing |
| 2023-10-16 | Injury | Endocarditis, Unspecified Infection, Heart Failure/Congestive Heart Failure | Appropriate Term/Code Not Available |
| 2023-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2023-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Electrical /Electronic Property Problem |
| 2023-10-05 | Injury | Abscess, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing, Device Sensing Problem |
| 2023-09-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2023-09-12 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-01 | Injury | No Clinical Signs, Symptoms or Conditions | Appropriate Term/Code Not Available |
| 2023-09-01 | Death | Insufficient Information | None |
| 2023-09-01 | Injury | Unspecified Infection | None |
| 2023-08-29 | Injury | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-08-01 | Injury | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-07-31 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-31 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-28 | Injury | No Clinical Signs, Symptoms or Conditions | Break |
| 2023-07-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-07-26 | Malfunction | Device Overstimulation of Tissue | Signal Artifact/Noise, Over-Sensing, Pocket Stimulation, High Capture Threshold |
| 2023-07-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-07-26 | Injury | No Clinical Signs, Symptoms or Conditions | Appropriate Term/Code Not Available |
| 2023-07-26 | Injury | Endocarditis | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-07-12 | Injury | No Clinical Signs, Symptoms or Conditions | Break |
| 2023-07-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pacing Problem, Device Dislodged or Dislocated |
| 2023-06-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-05-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pacing Problem |
| 2023-05-19 | Injury | Chest Pain, Dyspnea, Muscle Weakness/Atrophy, Pleural Effusion, Cardiac Tamponade, Pericardial Effusion, Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2023-05-19 | Injury | Chest Pain, Dyspnea, Muscle Weakness/Atrophy, Pleural Effusion, Cardiac Tamponade, Pericardial Effusion, Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2023-05-01 | Death | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-05-01 | Injury | Unspecified Infection, Undesired Nerve Stimulation, Vascular Dissection | Device Dislodged or Dislocated, High Capture Threshold |
| 2023-05-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem, High Capture Threshold |
| 2023-04-01 | Death | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-04-01 | Injury | Pulmonary Embolism, Stroke/CVA, Hemothorax, Myocardial Infarction, Pneumothorax, Cardiac Tamponade, Post Operative Wound Infection, Shock from Patient Lead(s), Pericardial Effusion, Syncope/Fainting, Thrombosis/Thrombus | Inappropriate/Inadequate Shock/Stimulation |
| 2023-03-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Over-Sensing, Impedance Problem |
| 2023-02-26 | Injury | Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-02-01 | Injury | Arrhythmia | None |
| 2023-01-31 | Death | Cardiac Arrest, Stroke/CVA, Unspecified Infection, Sepsis, Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2023-01-20 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-01-12 | Injury | Swollen Lymph Nodes/Glands | High impedance, Pacing Problem, High Capture Threshold |
| 2023-01-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2023-01-01 | Injury | Fistula, Hemorrhage/Blood Loss/Bleeding, Unspecified Infection, Sepsis, Pericardial Effusion, Heart Failure/Congestive Heart Failure, Tricuspid Valve Insufficiency/ Regurgitation | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Death | Unspecified Infection, Sepsis, Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2022-12-15 | Injury | Tricuspid Valve Insufficiency/ Regurgitation | Adverse Event Without Identified Device or Use Problem |
| 2022-12-14 | Injury | Unspecified Infection, Septic Shock | Adverse Event Without Identified Device or Use Problem |
| 2022-12-14 | Injury | Unspecified Infection, Septic Shock | Adverse Event Without Identified Device or Use Problem |
| 2022-12-14 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Appropriate Term/Code Not Available |
| 2022-12-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | High Capture Threshold |
| 2022-11-30 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, High Capture Threshold |
| 2022-11-17 | Malfunction | None | Failure to Capture, Device Dislodged or Dislocated |
| 2022-10-12 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2022-08-21 | Injury | No Clinical Signs, Symptoms or Conditions | High Capture Threshold |
| 2022-08-15 | Malfunction | None | Over-Sensing |
| 2022-07-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-06 | Malfunction | None | Over-Sensing |
| 2022-07-05 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2022-07-01 | Injury | None | Appropriate Term/Code Not Available |
| 2022-06-09 | Injury | No Clinical Signs, Symptoms or Conditions | Fracture |
| 2022-06-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-06-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-04-15 | Injury | None | Over-Sensing |
| 2022-04-01 | Injury | None | Device Dislodged or Dislocated |
| 2022-04-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-23 | Malfunction | None | Signal Artifact/Noise |
| 2022-03-02 | Malfunction | None | Failure to Capture, High Capture Threshold |
| 2022-01-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2022-01-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2021-09-12 | Death | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2021-02-09 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2021-02-09 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2019-09-24 | Malfunction | None | Activation, Positioning or Separation Problem |
| 2019-09-02 | Malfunction | None | Under-Sensing |
| 2019-08-29 | Malfunction | None | Fracture |
| 2019-08-25 | Injury | None | Over-Sensing |
| 2019-08-14 | Malfunction | None | Over-Sensing |
| 2019-08-13 | Malfunction | None | Capturing Problem |
| 2019-08-13 | Injury | None | Over-Sensing |
| 2019-08-08 | Malfunction | None | High impedance, Impedance Problem |
| 2019-08-06 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-18 | Injury | None | Fracture, Inappropriate/Inadequate Shock/Stimulation |
| 2019-06-24 | Malfunction | None | Appropriate Term/Code Not Available |
| 2019-06-21 | Malfunction | None | High Capture Threshold |
| 2019-06-14 | Injury | None | Fracture, Over-Sensing |
| 2019-06-13 | Malfunction | None | High Capture Threshold |
| 2019-05-27 | Injury | None | High Capture Threshold |
| 2019-05-27 | Injury | None | High impedance |
| 2019-05-20 | Malfunction | None | High impedance, Pacing Problem, High Capture Threshold |
| 2019-05-20 | Malfunction | None | Break |
| 2019-05-17 | Malfunction | None | No Apparent Adverse Event |
| 2019-05-16 | Injury | None | Failure to Capture, High impedance, High Capture Threshold |
| 2019-05-16 | Malfunction | None | Low impedance, Capturing Problem, High Capture Threshold |
| 2019-04-30 | Malfunction | None | Capturing Problem, Device Dislodged or Dislocated |
| 2019-04-30 | Injury | None | Over-Sensing |
| 2019-04-26 | Injury | None | Capturing Problem, Positioning Problem |
| 2019-04-24 | Injury | None | Capturing Problem, Positioning Problem |
| 2019-04-22 | Malfunction | None | Mechanical Problem |
| 2019-04-19 | Malfunction | None | Degraded |
| 2019-04-09 | Injury | None | Break |
| 2019-04-09 | Injury | None | Break |
| 2019-04-04 | Injury | None | Break |
| 2019-04-01 | Malfunction | None | High impedance |
| 2019-04-01 | Injury | None | Positioning Problem, High Capture Threshold |
| 2019-03-25 | Injury | None | Over-Sensing |
| 2019-03-25 | Malfunction | None | Over-Sensing |
| 2019-03-19 | Malfunction | None | Corroded |
| 2019-03-14 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2019-03-14 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2019-03-14 | Malfunction | None | Decreased Sensitivity |
| 2019-03-06 | Malfunction | None | Over-Sensing, Decreased Sensitivity, Impedance Problem, Unstable Capture Threshold |
| 2019-03-04 | Malfunction | None | Appropriate Term/Code Not Available |
| 2019-03-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-27 | Injury | None | Fracture |
| 2019-02-22 | Injury | None | Positioning Problem |
| 2019-02-22 | Injury | None | Signal Artifact/Noise, Break, Low impedance |
| 2019-02-07 | Injury | None | Over-Sensing, Low impedance |
| 2019-02-01 | Malfunction | None | Capturing Problem |
| 2019-01-30 | Malfunction | None | Appropriate Term/Code Not Available |
| 2019-01-24 | Malfunction | None | High Capture Threshold |
| 2019-01-24 | Injury | None | Failure to Capture |
| 2019-01-23 | Malfunction | None | Over-Sensing |
| 2019-01-22 | Malfunction | None | High Capture Threshold |
| 2019-01-16 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2019-01-13 | Malfunction | None | High Capture Threshold |
| 2019-01-11 | Injury | None | Pacing Problem |
| 2019-01-09 | Injury | None | Appropriate Term/Code Not Available |
| 2019-01-07 | Malfunction | None | Over-Sensing, High Capture Threshold |
| 2019-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-01 | Injury | None | Impedance Problem |
| 2019-01-01 | Injury | None | Pacing Problem, Stretched, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Positioning Problem, Migration |
| 2019-01-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-01 | Injury | None | Device Dislodged or Dislocated |
| 2019-01-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-01 | Injury | None | Pacing Problem, Under-Sensing, Low impedance, Decreased Sensitivity |
| 2019-01-01 | Injury | None | Failure to Capture, Fracture |
| 2019-01-01 | Malfunction | None | Failure to Capture, Fracture, Device Sensing Problem, Impedance Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-12-28 | Injury | None | Device Dislodged or Dislocated, Appropriate Term/Code Not Available |
| 2018-12-20 | Injury | None | Over-Sensing |
| 2018-12-19 | Injury | None | Adverse Event Without Identified Device or Use Problem, High Capture Threshold |
| 2018-12-08 | Injury | None | Failure to Capture |
| 2018-12-07 | Injury | None | Failure to Capture |
| 2018-12-06 | Malfunction | None | Impedance Problem |
| 2018-12-05 | Malfunction | None | Mechanical Problem |
| 2018-12-04 | Injury | None | Fracture, High impedance, Impedance Problem, Appropriate Term/Code Not Available |
| 2018-12-04 | Injury | None | Appropriate Term/Code Not Available |
| 2018-12-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-29 | Malfunction | None | Fracture, High impedance, Over-Sensing |
| 2018-11-26 | Injury | None | Appropriate Term/Code Not Available |
| 2018-11-22 | Malfunction | None | High impedance |
| 2018-11-13 | Malfunction | None | Activation, Positioning or Separation Problem |
| 2018-11-09 | Injury | None | Intermittent Capture |
| 2018-11-08 | Injury | None | Device Dislodged or Dislocated |
| 2018-11-04 | Malfunction | None | Break, Pacing Problem, Low impedance |
| 2018-11-02 | Injury | None | Fracture |
| 2018-10-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-26 | Injury | None | Failure to Capture |
| 2018-10-24 | Injury | None | Intermittent Capture, Device Dislodged or Dislocated |
| 2018-10-24 | Injury | None | Under-Sensing |
| 2018-10-21 | Injury | None | Signal Artifact/Noise, Failure to Capture |
| 2018-10-21 | Injury | None | Fracture |
| 2018-10-19 | Injury | None | Over-Sensing |
| 2018-10-19 | Injury | None | Over-Sensing, Connection Problem |
| 2018-10-10 | Injury | None | Insufficient Information |
| 2018-10-08 | Injury | None | High impedance, High Capture Threshold |
| 2018-10-05 | Malfunction | None | High impedance, Impedance Problem |
| 2018-10-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-30 | Injury | None | Fracture, Over-Sensing, Low impedance |
| 2018-09-26 | Injury | None | Failure to Capture, High Capture Threshold, Unstable Capture Threshold |
| 2018-09-25 | Malfunction | None | Over-Sensing |
| 2018-09-24 | Malfunction | None | Over-Sensing |
| 2018-09-19 | Injury | None | Signal Artifact/Noise |
| 2018-09-17 | Malfunction | None | Pocket Stimulation, Impedance Problem |
| 2018-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-14 | Malfunction | None | Fracture |
| 2018-09-13 | Malfunction | None | Under-Sensing |
| 2018-09-07 | Malfunction | None | High impedance, Impedance Problem, High Capture Threshold |
| 2018-09-06 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-08-30 | Injury | None | High impedance |
| 2018-08-28 | Malfunction | None | High impedance, Over-Sensing |
| 2018-08-28 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-08-27 | Injury | None | Appropriate Term/Code Not Available |
| 2018-08-24 | Malfunction | None | High Capture Threshold |
| 2018-08-23 | Injury | None | Capturing Problem, Positioning Problem |
| 2018-08-20 | Injury | None | High Capture Threshold |
| 2018-08-16 | Malfunction | None | Connection Problem |
| 2018-08-15 | Malfunction | None | Fracture |
| 2018-07-26 | Injury | None | Over-Sensing, Under-Sensing |
| 2018-07-25 | Injury | None | Under-Sensing |
| 2018-07-18 | Malfunction | None | Over-Sensing, Decreased Sensitivity |
| 2018-07-16 | Injury | None | High Sensing Threshold, Capturing Problem |
| 2018-07-09 | Injury | None | Premature Discharge of Battery, High Capture Threshold |
| 2018-07-04 | Injury | None | Pacing Problem, Under-Sensing |
| 2018-06-26 | Malfunction | None | Signal Artifact/Noise, Over-Sensing |
| 2018-06-26 | Injury | None | Insufficient Information |
| 2018-06-23 | Injury | None | Over-Sensing, Device Sensing Problem |
| 2018-06-19 | Malfunction | None | Under-Sensing |
| 2018-06-19 | Injury | None | Device Dislodged or Dislocated |
| 2018-06-14 | Malfunction | None | Capturing Problem, Impedance Problem |
| 2018-06-14 | Injury | None | Patient-Device Incompatibility, Unstable Capture Threshold |
| 2018-06-12 | Injury | None | Under-Sensing |
| 2018-06-11 | Malfunction | None | Over-Sensing, Under-Sensing |
| 2018-06-04 | Injury | None | Break, Device Dislodged or Dislocated, Impedance Problem, Adverse Event Without Identified Device or Use Problem, High Capture Threshold |
| 2018-06-04 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2018-06-04 | Malfunction | None | Device Dislodged or Dislocated |
| 2018-05-29 | Malfunction | None | Low impedance |
| 2018-05-24 | Injury | None | Capturing Problem |
| 2018-05-24 | Injury | None | High impedance, Connection Problem |
| 2018-05-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-21 | Injury | None | Pacing Problem, Pacing Inadequately, Capturing Problem |
| 2018-05-21 | Injury | None | Fracture |
| 2018-05-21 | Malfunction | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-05-17 | Malfunction | None | Over-Sensing |
| 2018-05-17 | Malfunction | None | Fracture, High impedance |
| 2018-05-16 | Injury | None | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Positioning Problem, High Capture Threshold |
| 2018-05-16 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-12 | Malfunction | None | Fracture |
| 2018-05-11 | Malfunction | None | Over-Sensing |
| 2018-05-09 | Malfunction | None | Over-Sensing, Under-Sensing |
| 2018-05-07 | Injury | None | Fracture, Over-Sensing |
| 2018-05-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-03 | Malfunction | None | High Capture Threshold |
| 2018-05-02 | Injury | None | Under-Sensing, Decreased Sensitivity |
| 2018-05-01 | Malfunction | None | Insufficient Information |
| 2018-05-01 | Injury | None | Loose or Intermittent Connection, Pacing Problem |
| 2018-04-24 | Malfunction | None | High Capture Threshold |
| 2018-04-20 | Malfunction | None | Under-Sensing |
| 2018-04-19 | Injury | None | Over-Sensing |
| 2018-04-18 | Malfunction | None | Positioning Problem, High Capture Threshold, Unstable Capture Threshold |
| 2018-04-17 | Malfunction | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-04-17 | Malfunction | None | Positioning Problem, High Capture Threshold |
| 2018-04-14 | Injury | None | High impedance, Low impedance, High Capture Threshold |
| 2018-04-13 | Malfunction | None | Over-Sensing |
| 2018-04-11 | Malfunction | None | Failure to Capture, Unstable Capture Threshold |
| 2018-04-10 | Malfunction | None | Over-Sensing |
| 2018-04-10 | Malfunction | None | Mechanical Problem |
| 2018-04-10 | Injury | None | Appropriate Term/Code Not Available |
| 2018-04-10 | Malfunction | None | Degraded |
| 2018-04-05 | Malfunction | None | Signal Artifact/Noise |
| 2018-03-22 | Malfunction | None | Over-Sensing |
| 2018-03-21 | Malfunction | None | Over-Sensing |
| 2018-03-20 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2018-03-20 | Death | None | Fracture, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2018-03-15 | Malfunction | None | Signal Artifact/Noise, Failure to Capture, Low impedance |
| 2018-03-14 | Injury | None | Over-Sensing |
| 2018-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-06 | Injury | None | Fracture, High impedance, Material Deformation, Appropriate Term/Code Not Available |
| 2018-03-01 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-02-28 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-28 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-26 | Malfunction | None | Positioning Problem |
| 2018-02-22 | Malfunction | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2018-02-22 | Injury | None | Over-Sensing, Device Sensing Problem |
| 2018-02-15 | Malfunction | None | High Capture Threshold |
| 2018-02-13 | Injury | None | Device Dislodged or Dislocated |
| 2018-02-13 | Death | None | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2018-02-11 | Injury | None | Capturing Problem, High Capture Threshold |
| 2018-02-08 | Malfunction | None | Degraded |
| 2018-02-08 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-02-08 | Malfunction | None | High impedance, Impedance Problem |
| 2018-02-06 | Malfunction | None | Over-Sensing |
| 2018-01-17 | Malfunction | None | High impedance, Pacing Problem |
| 2018-01-17 | Malfunction | None | Failure to Capture |
| 2018-01-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Failure to Capture, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Break, Fracture, Inappropriate/Inadequate Shock/Stimulation, Impedance Problem |
| 2018-01-01 | Death | None | Positioning Problem |
| 2018-01-01 | Injury | None | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Over-Sensing, Device Dislodged or Dislocated |
| 2018-01-01 | Injury | None | Device Sensing Problem, Impedance Problem, Unstable Capture Threshold |
| 2018-01-01 | Injury | None | Signal Artifact/Noise, Over-Sensing |
| 2018-01-01 | Injury | None | Appropriate Term/Code Not Available |
| 2018-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Malfunction | None | Capturing Problem, Impedance Problem |
| 2018-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Fracture, Inappropriate/Inadequate Shock/Stimulation, Capturing Problem, Device Sensing Problem, Impedance Problem |
| 2018-01-01 | Injury | None | Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Impedance Problem |
| 2018-01-01 | Malfunction | None | Over-Sensing, High Capture Threshold |
| 2018-01-01 | Death | None | Device Dislodged or Dislocated |
| 2018-01-01 | Injury | None | Capturing Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Capturing Problem |
| 2018-01-01 | Injury | None | Electromagnetic Interference, Over-Sensing, Capturing Problem, Device Sensing Problem |
| 2018-01-01 | Injury | None | Over-Sensing, Capturing Problem |
| 2017-12-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-20 | Injury | None | Pacing Problem |
| 2017-12-20 | Injury | None | Appropriate Term/Code Not Available |
| 2017-12-13 | Injury | None | Break |
| 2017-12-13 | Injury | None | Break |
| 2017-12-13 | Injury | None | Break |
| 2017-12-13 | Injury | None | Break |
| 2017-12-11 | Malfunction | None | Device Sensing Problem |
| 2017-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-05 | Malfunction | None | High impedance, Impedance Problem |
| 2017-11-30 | Injury | None | Positioning Problem |
| 2017-11-30 | Malfunction | None | High impedance, High Capture Threshold |
| 2017-11-25 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-11-23 | Injury | None | Failure to Capture |
| 2017-11-21 | Injury | None | Fracture, High impedance |
| 2017-11-21 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-11-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-14 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-11-13 | Injury | None | High Capture Threshold |
| 2017-11-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-07 | Injury | None | Failure to Capture |
| 2017-11-02 | Malfunction | None | Impedance Problem |
| 2017-10-31 | Malfunction | None | Capturing Problem, Device Dislodged or Dislocated |
| 2017-10-31 | Malfunction | None | Capturing Problem, Device Dislodged or Dislocated |
| 2017-10-29 | Injury | None | Under-Sensing |
| 2017-10-25 | Malfunction | None | Under-Sensing |
| 2017-10-25 | Injury | None | High Capture Threshold |
| 2017-10-24 | Malfunction | None | Under-Sensing |
| 2017-10-20 | Injury | None | Fracture, Inappropriate/Inadequate Shock/Stimulation |
| 2017-10-18 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-10-18 | Malfunction | None | Low impedance |
| 2017-10-17 | Injury | None | Capturing Problem |
| 2017-10-10 | Malfunction | None | Over-Sensing |
| 2017-10-10 | Injury | None | High Capture Threshold |
| 2017-10-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-27 | Injury | None | Low impedance |
| 2017-09-24 | Injury | None | Device Dislodged or Dislocated |
| 2017-09-24 | Malfunction | None | Over-Sensing |
| 2017-09-10 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-02 | Injury | None | Fracture, High impedance |
| 2017-09-01 | Injury | None | Capturing Problem, Connection Problem |
| 2017-08-28 | Malfunction | None | Failure to Capture, Over-Sensing, Under-Sensing |
| 2017-08-17 | Malfunction | None | Failure to Capture, Failure to Sense, Under-Sensing |
| 2017-08-14 | Malfunction | None | Signal Artifact/Noise |
| 2017-08-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-08-03 | Injury | None | High impedance |
| 2017-07-30 | Death | None | Break, Fracture, Adverse Event Without Identified Device or Use Problem |
| 2017-07-26 | Injury | None | Fracture, Inappropriate/Inadequate Shock/Stimulation |
| 2017-07-25 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-25 | Injury | None | Fracture, Inappropriate/Inadequate Shock/Stimulation, Impedance Problem |
| 2017-07-20 | Malfunction | None | Break |
| 2017-07-20 | Malfunction | None | Break |
| 2017-07-20 | Malfunction | None | Break |
| 2017-07-19 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-19 | Malfunction | None | Degraded |
| 2017-07-17 | Malfunction | None | Break |
| 2017-07-17 | Injury | None | High Capture Threshold |
| 2017-07-14 | Injury | None | Decreased Sensitivity, Capturing Problem |
| 2017-07-10 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-07-05 | Malfunction | None | Appropriate Term/Code Not Available |
| 2017-07-05 | Malfunction | None | Appropriate Term/Code Not Available |
| 2017-07-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-23 | Injury | None | Device Dislodged or Dislocated |
| 2017-06-21 | Injury | None | High Capture Threshold |
| 2017-06-16 | Malfunction | None | Capturing Problem, Device Dislodged or Dislocated |
| 2017-06-15 | Malfunction | None | High impedance, Capturing Problem, Positioning Problem |
| 2017-06-15 | Injury | None | Mechanical Problem, Electronic Property Issue |
| 2017-06-09 | Death | None | Device Dislodged or Dislocated, Positioning Problem |
| 2017-06-07 | Injury | None | High impedance, High Capture Threshold |
| 2017-06-05 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-06-01 | Injury | None | High Capture Threshold |
| 2017-06-01 | Injury | None | Over-Sensing, Decreased Sensitivity |
| 2017-06-01 | Injury | None | Appropriate Term/Code Not Available |
| 2017-05-24 | Injury | None | High Capture Threshold |
| 2017-05-05 | Injury | None | Over-Sensing |
| 2017-04-28 | Malfunction | None | Over-Sensing |
| 2017-04-25 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2017-04-25 | Death | None | Detachment Of Device Component |
| 2017-04-24 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-20 | Injury | None | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Positioning Problem |
| 2017-04-18 | Injury | None | Pacing Problem, Device Sensing Problem, Impedance Problem |
| 2017-04-13 | Injury | None | Insufficient Information |
| 2017-04-04 | Injury | None | Fracture |
| 2017-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-17 | Injury | None | Adverse Event Without Identified Device or Use Problem, Positioning Problem |
| 2017-03-14 | Death | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2017-03-10 | Injury | None | High impedance, Electronic Property Issue |
| 2017-03-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-07 | Injury | None | Unstable Capture Threshold |
| 2017-03-07 | Injury | None | Under-Sensing |
| 2017-03-07 | Injury | None | Capturing Problem, High Capture Threshold |
| 2017-03-06 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-03-01 | Injury | None | Break |
| 2017-03-01 | Malfunction | None | Decreased Sensitivity |
| 2017-02-28 | Injury | None | Fracture, High impedance, High Capture Threshold |
| 2017-02-24 | Injury | None | Signal Artifact/Noise, Pacing Problem |
| 2017-02-24 | Injury | None | Signal Artifact/Noise |
| 2017-02-21 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-02-09 | Malfunction | None | Degraded |
| 2017-02-09 | Malfunction | None | Material Deformation |
| 2017-02-08 | Malfunction | None | Product Quality Problem |
| 2017-02-07 | Malfunction | None | Signal Artifact/Noise, Over-Sensing, Under-Sensing, Low impedance, Impedance Problem |
| 2017-02-06 | Malfunction | None | High impedance |
| 2017-02-01 | Malfunction | None | Fracture |
| 2017-02-01 | Malfunction | None | Mechanical Problem, Over-Sensing |
| 2017-02-01 | Malfunction | None | Mechanical Problem, Over-Sensing |
| 2017-02-01 | Injury | None | High impedance, High Sensing Threshold, High Capture Threshold |
| 2017-02-01 | Injury | None | High impedance, High Sensing Threshold, Connection Problem, High Capture Threshold |
| 2017-01-18 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-01-13 | Death | None | Fracture, No Pacing |
| 2017-01-03 | Malfunction | None | Capturing Problem |
| 2017-01-03 | Death | None | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2017-01-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-01 | Death | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-01-01 | Death | None | Device Dislodged or Dislocated, Positioning Problem |
| 2017-01-01 | Injury | None | Break, Fracture, High impedance, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Decreased Sensitivity, Device Dislodged or Dislocated |
| 2017-01-01 | Injury | None | Malposition of Device, Device Dislodged or Dislocated |
| 2017-01-01 | Injury | None | Capturing Problem |
| 2017-01-01 | Malfunction | None | Capturing Problem |
| 2017-01-01 | Injury | None | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available |
| 2017-01-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-01 | Death | None | Positioning Problem |
| 2017-01-01 | Injury | None | Signal Artifact/Noise, Electromagnetic Interference, Fracture, Over-Sensing, Capturing Problem, Device Sensing Problem, Device Dislodged or Dislocated |
| 2016-12-28 | Injury | None | Over-Sensing, Under-Sensing |
| 2016-12-22 | Injury | None | Impedance Problem, High Capture Threshold, Unstable Capture Threshold |
| 2016-12-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-06 | Injury | None | Failure to Capture, Low impedance, High Capture Threshold |
| 2016-12-02 | Injury | None | High Capture Threshold |
| 2016-11-30 | Malfunction | None | Break |
| 2016-11-28 | Malfunction | None | Failure to Capture, Device Dislodged or Dislocated |
| 2016-11-28 | Malfunction | None | Over-Sensing |
| 2016-11-26 | Injury | None | Device Dislodged or Dislocated |
| 2016-11-22 | Injury | None | Appropriate Term/Code Not Available |
| 2016-11-20 | Injury | None | High impedance |
| 2016-11-16 | Malfunction | None | Low impedance |
| 2016-11-07 | Malfunction | None | Fracture |
| 2016-11-01 | Injury | None | Failure to Capture, High impedance, Device Dislodged or Dislocated, Impedance Problem, Appropriate Term/Code Not Available, High Capture Threshold |
| 2016-11-01 | Injury | None | Fracture, Inappropriate/Inadequate Shock/Stimulation, Connection Problem, Device Dislodged or Dislocated, Impedance Problem |
| 2016-10-31 | Injury | None | Low impedance, Impedance Problem, High Capture Threshold, Unstable Capture Threshold |
| 2016-10-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-27 | Malfunction | None | High impedance |
| 2016-10-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-24 | Injury | None | Break, Fracture, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2016-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-14 | Malfunction | None | Appropriate Term/Code Not Available |
| 2016-10-06 | Injury | None | Failure to Capture |
| 2016-10-01 | Malfunction | None | High impedance, Mechanical Problem |
| 2016-09-28 | Malfunction | None | Low impedance |
| 2016-09-23 | Injury | None | Failure to Capture |
| 2016-09-23 | Injury | None | Failure to Capture |
| 2016-09-17 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-10 | Injury | None | Failure to Capture, Fracture, High impedance, Electronic Property Issue, High Capture Threshold |
| 2016-09-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-28 | Injury | None | High Capture Threshold |
| 2016-08-26 | Injury | None | Failure to Capture, Under-Sensing, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, High Capture Threshold |
| 2016-08-23 | Injury | None | Fracture, Inappropriate/Inadequate Shock/Stimulation |
| 2016-08-22 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2016-08-17 | Malfunction | None | Shelf Life Exceeded |
| 2016-08-13 | Malfunction | None | High Capture Threshold |
| 2016-08-11 | Injury | None | Fracture, Material Deformation |
| 2016-08-11 | Injury | None | High Capture Threshold |
| 2016-08-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-08 | Injury | None | Break |
| 2016-08-01 | Malfunction | None | High impedance, High Capture Threshold |
| 2016-08-01 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2016-08-01 | Malfunction | None | High impedance, High Capture Threshold |
| 2016-08-01 | Injury | None | Pocket Stimulation |
| 2016-08-01 | Injury | None | Device Dislodged or Dislocated, Appropriate Term/Code Not Available |
| 2016-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-27 | Injury | None | Under-Sensing, High Capture Threshold |
| 2016-07-27 | Injury | None | High Capture Threshold |
| 2016-07-12 | Malfunction | None | Fracture |
| 2016-07-10 | Injury | None | Signal Artifact/Noise, High impedance |
| 2016-07-10 | Injury | None | Signal Artifact/Noise, High impedance |
| 2016-07-08 | Malfunction | None | Capturing Problem |
| 2016-07-08 | Injury | None | Capturing Problem |
| 2016-07-02 | Injury | None | Capturing Problem, Device Sensing Problem, Device Dislodged or Dislocated |
| 2016-07-01 | Injury | None | Appropriate Term/Code Not Available |
| 2016-07-01 | Injury | None | Signal Artifact/Noise, Fracture, Under-Sensing, Impedance Problem |
| 2016-07-01 | Injury | None | High Capture Threshold |
| 2016-07-01 | Injury | None | Fracture, Failure to Convert Rhythm, Defibrillation/Stimulation Problem, Inappropriate/Inadequate Shock/Stimulation, Device Dislodged or Dislocated |
| 2016-06-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-27 | Injury | None | Fracture, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2016-06-19 | Malfunction | None | Mechanical Problem, Low impedance |
| 2016-06-17 | Injury | None | Fracture, High impedance |
| 2016-06-16 | Injury | None | Appropriate Term/Code Not Available |
| 2016-06-07 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2016-06-04 | Malfunction | None | Impedance Problem |
| 2016-05-25 | Malfunction | None | Over-Sensing |
| 2016-05-23 | Injury | None | Device Markings/Labelling Problem |
| 2016-05-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-19 | Injury | None | Connection Problem, Device Dislodged or Dislocated |
| 2016-05-19 | Malfunction | None | High Capture Threshold |
| 2016-05-18 | Injury | None | Fracture, High impedance, Appropriate Term/Code Not Available |
| 2016-05-12 | Injury | None | Device Dislodged or Dislocated |
| 2016-05-10 | Malfunction | None | Under-Sensing |
| 2016-05-09 | Malfunction | None | Capturing Problem, Positioning Problem |
| 2016-04-29 | Injury | None | Fracture, Appropriate Term/Code Not Available |
| 2016-04-26 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2016-04-23 | Malfunction | None | High impedance, Capturing Problem |
| 2016-04-21 | Malfunction | None | Fracture |
| 2016-04-20 | Injury | None | Appropriate Term/Code Not Available |
| 2016-04-01 | Malfunction | None | Low impedance, Capturing Problem, Impedance Problem |
| 2016-03-29 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2016-03-22 | Injury | None | Fracture, Mechanical Problem, Over-Sensing |
| 2016-03-15 | Malfunction | None | Mechanical Problem, Low impedance |
| 2016-03-11 | Malfunction | None | Positioning Problem |
| 2016-02-22 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-02-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-29 | Malfunction | None | Electromagnetic Interference, Over-Sensing, Pacing Problem, Electronic Property Issue |
| 2016-01-15 | Injury | None | Break, Over-Sensing, Low impedance |
| 2016-01-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-01 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2016-01-01 | Injury | None | Device Dislodged or Dislocated |
| 2016-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-01 | Injury | None | Device Dislodged or Dislocated |
| 2016-01-01 | Injury | None | Break, Crack, Device Dislodged or Dislocated |
| 2016-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2016-01-01 | Death | None | Fracture, Capturing Problem, Device Dislodged or Dislocated |
| 2016-01-01 | Injury | None | Capturing Problem, High Capture Threshold |
| 2016-01-01 | Death | None | Appropriate Term/Code Not Available |
| 2016-01-01 | Injury | None | High Capture Threshold |
| 2016-01-01 | Death | None | Failure to Capture, Kinked, Under-Sensing, Capturing Problem, Impedance Problem |
| 2016-01-01 | Death | None | Connection Problem, Device Dislodged or Dislocated |
| 2015-11-05 | Injury | None | Device Dislodged or Dislocated |
| 2015-11-05 | Injury | None | Device Dislodged or Dislocated |
| 2015-09-11 | Malfunction | None | Fracture |
| 2015-09-02 | Malfunction | None | Over-Sensing, Pacing Problem |
| 2015-09-02 | Malfunction | None | Over-Sensing, Pacing Problem |
| 2015-06-01 | Injury | None | High impedance |
| 2015-05-19 | Malfunction | None | Activation, Positioning or Separation Problem, Device Dislodged or Dislocated |
| 2015-05-19 | Malfunction | None | Activation, Positioning or Separation Problem, Device Dislodged or Dislocated |
| 2015-04-21 | Injury | None | Low impedance |
| 2015-04-01 | Death | None | Capturing Problem, Impedance Problem |
| 2015-03-01 | Death | None | Fracture, Failure to Sense, Cut In Material, Capturing Problem |
| 2015-02-01 | Death | None | Failure to Advance, Adverse Event Without Identified Device or Use Problem |
| 2015-01-22 | Malfunction | None | Failure to Capture, Capturing Problem |
| 2015-01-01 | Injury | None | Break, Fracture, High impedance, Inappropriate/Inadequate Shock/Stimulation, Cut In Material, Capturing Problem |
| 2015-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-12-01 | Death | None | Inappropriate/Inadequate Shock/Stimulation, Capturing Problem, Positioning Problem |
| 2014-08-01 | Injury | None | Appropriate Term/Code Not Available |
| 2014-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-06-18 | Malfunction | None | Under-Sensing |
| 2014-06-17 | Injury | None | Break |
| 2014-06-13 | Injury | None | Fracture |
| 2014-06-06 | Injury | None | High impedance, Loose or Intermittent Connection, High Capture Threshold |
| 2014-06-03 | Malfunction | None | High Capture Threshold |
| 2014-05-28 | Malfunction | None | Under-Sensing |
| 2014-05-23 | Injury | None | Mechanical Problem |
| 2014-05-01 | Death | None | Fracture |
| 2014-04-29 | Injury | None | Under-Sensing |
| 2014-04-10 | Injury | None | Connection Problem |
| 2014-04-09 | Injury | None | High impedance |
| 2014-04-01 | Injury | None | Electrical /Electronic Property Problem, Under-Sensing |
| 2014-03-20 | Injury | None | High Capture Threshold |
| 2014-03-11 | Injury | None | Break |
| 2014-03-11 | Injury | None | Break |
| 2014-03-10 | Injury | None | Device Dislodged or Dislocated |
| 2014-03-06 | Malfunction | None | Break |
| 2014-02-25 | Injury | None | High Capture Threshold |
| 2014-02-25 | Injury | None | High Capture Threshold |
| 2014-02-23 | Injury | None | Detachment Of Device Component |
| 2014-02-17 | Malfunction | None | Signal Artifact/Noise, Over-Sensing |
| 2014-02-14 | Malfunction | None | High impedance |
| 2014-02-11 | Malfunction | None | Appropriate Term/Code Not Available |
| 2014-02-05 | Injury | None | Patient-Device Incompatibility |
| 2014-02-05 | Injury | None | Fracture |
| 2014-02-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, High Capture Threshold |
| 2014-02-01 | Death | None | Fracture, Inappropriate/Inadequate Shock/Stimulation |
| 2014-01-29 | Injury | None | Fracture |
| 2014-01-23 | Injury | None | Break |
| 2014-01-19 | Injury | None | High impedance, Impedance Problem |
| 2014-01-10 | Malfunction | None | Signal Artifact/Noise, Over-Sensing |
| 2014-01-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-01-09 | Malfunction | None | Over-Sensing, Impedance Problem |
| 2014-01-08 | Malfunction | None | Unstable Capture Threshold |
| 2014-01-07 | Malfunction | None | Low impedance |
| 2014-01-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-01 | Death | None | Break, Fracture, Capturing Problem, Impedance Problem, Unstable Capture Threshold |
| 2014-01-01 | Injury | None | Appropriate Term/Code Not Available |
| 2014-01-01 | Death | None | Signal Artifact/Noise, High Capture Threshold |
| 2014-01-01 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2014-01-01 | Death | None | Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2013-12-04 | Injury | None | Fracture |
| 2013-12-04 | Injury | None | Break |
| 2013-12-01 | Injury | None | Over-Sensing, Under-Sensing |
| 2013-12-01 | Injury | None | Break |
| 2013-11-27 | Injury | None | Signal Artifact/Noise, Loose or Intermittent Connection |
| 2013-11-22 | Injury | None | Device Dislodged or Dislocated |
| 2013-11-20 | Malfunction | None | Fracture |
| 2013-11-20 | Malfunction | None | Capturing Problem, Impedance Problem |
| 2013-11-18 | Injury | None | Device Operates Differently Than Expected |
| 2013-11-18 | Malfunction | None | Capturing Problem |
| 2013-11-13 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2013-11-12 | Death | None | None |
| 2013-10-28 | Injury | None | None |
| 2013-10-15 | Injury | None | Pacing Problem, Device Dislodged or Dislocated |
| 2013-09-30 | Malfunction | None | None |
| 2013-09-19 | Injury | None | None |
| 2013-09-19 | Malfunction | None | None |
| 2013-09-18 | Malfunction | None | None |
| 2013-09-16 | Malfunction | None | None |
| 2013-09-06 | Malfunction | None | None |
| 2013-09-04 | Malfunction | None | None |
| 2013-09-01 | Injury | None | Device Dislodged or Dislocated |
| 2013-09-01 | Death | None | None |
| 2013-08-15 | Injury | None | None |
| 2013-08-02 | Injury | None | None |
| 2013-08-02 | Malfunction | None | Failure to Capture |
| 2013-08-01 | Injury | None | None |
| 2013-07-30 | Injury | None | High impedance |
| 2013-07-11 | Malfunction | None | None |
| 2013-07-08 | Injury | None | None |
| 2013-07-01 | Injury | None | None |
| 2013-06-14 | Injury | None | Break |
| 2013-06-11 | Injury | None | Break, Low impedance, Impedance Problem |
| 2013-06-11 | Injury | None | None |
| 2013-06-08 | Injury | None | None |
| 2013-06-07 | Injury | None | None |
| 2013-06-07 | Malfunction | None | None |
| 2013-06-07 | Malfunction | None | None |
| 2013-06-01 | Injury | None | Capturing Problem |
| 2013-06-01 | Death | None | None |
| 2013-05-23 | Injury | None | None |
| 2013-05-21 | Malfunction | None | None |
| 2013-04-24 | Injury | None | None |
| 2013-04-18 | Injury | Bacterial Infection | Adverse Event Without Identified Device or Use Problem |
| 2013-04-18 | Injury | None | Positioning Problem |
| 2013-04-08 | Malfunction | None | None |
| 2013-04-05 | Injury | None | None |
| 2013-04-02 | Injury | None | None |
| 2013-04-01 | Malfunction | None | None |
| 2013-03-18 | Malfunction | None | Deformation Due to Compressive Stress, Appropriate Term/Code Not Available |
| 2013-03-13 | Malfunction | None | None |
| 2013-03-04 | Injury | None | None |
| 2013-02-18 | Injury | None | None |
| 2013-02-04 | Injury | None | None |
| 2013-02-01 | Injury | None | None |
| 2013-01-21 | Injury | None | None |
| 2013-01-16 | Injury | None | None |
| 2013-01-16 | Injury | None | None |
| 2013-01-15 | Injury | None | None |
| 2013-01-10 | Malfunction | None | None |
| 2013-01-10 | Malfunction | None | None |
| 2013-01-09 | Death | None | None |
| 2013-01-08 | Injury | None | None |
| 2013-01-01 | Injury | None | Fracture |
| 2013-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-01-01 | Injury | None | Device Sensing Problem |
| 2013-01-01 | Injury | None | Device Operates Differently Than Expected |
| 2013-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-12-21 | Injury | None | None |
| 2012-12-18 | Death | None | None |
| 2012-12-06 | Injury | None | None |
| 2012-12-01 | Malfunction | None | None |
| 2012-11-20 | Injury | None | None |
| 2012-11-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-11-07 | Death | None | None |
| 2012-11-07 | Death | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-10-25 | Injury | None | None |
| 2012-10-25 | Injury | None | None |
| 2012-10-11 | Death | None | None |
| 2012-10-09 | Injury | None | None |
| 2012-10-04 | Injury | None | None |
| 2012-10-03 | Injury | None | None |
| 2012-09-19 | Malfunction | None | High impedance, Mechanical Problem, Protective Measures Problem |
| 2012-09-19 | Malfunction | None | High impedance, Mechanical Problem, Protective Measures Problem |
| 2012-09-07 | Injury | None | None |
| 2012-05-01 | Injury | None | Device Dislodged or Dislocated |
| 2012-02-19 | Injury | None | Impedance Problem |
| 2012-01-01 | Injury | None | Break, Detachment Of Device Component, Crack, Fracture, Mechanical Problem, Cut In Material, Device-Device Incompatibility, Material Protrusion/Extrusion |
| 2012-01-01 | Injury | None | Difficult to Remove, Device Dislodged or Dislocated |
| 2012-01-01 | Injury | None | Difficult to Remove |
| 2012-01-01 | Death | None | Fracture, Difficult to Remove, Capturing Problem, Device Dislodged or Dislocated |
| 2011-09-01 | Death | None | Unable to Obtain Readings |
| 2011-09-01 | Death | None | Unable to Obtain Readings, Device Handling Problem |
| 2011-08-12 | Injury | None | None |
| 2011-03-01 | Injury | None | Failure to Capture, Failure to Sense, Under-Sensing, Device Dislodged or Dislocated |
| 2010-07-03 | Malfunction | None | None |
| 2010-06-27 | Injury | None | Difficult to Remove |
| 2010-06-08 | Injury | None | Product Quality Problem |
| 2010-05-01 | Death | None | High Capture Threshold |
| 2010-01-12 | Injury | None | None |
| 2010-01-01 | Death | None | Signal Artifact/Noise, Fracture, High impedance, Impedance Problem, Device Handling Problem, Unstable Capture Threshold |
| 2010-01-01 | Death | None | Appropriate Term/Code Not Available |
| 2010-01-01 | Injury | None | High impedance |
| 2009-12-28 | Malfunction | None | Unstable Capture Threshold |
| 2009-10-27 | Injury | None | None |
| 2009-08-01 | Death | None | Fracture, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Device Dislodged or Dislocated |
| 2009-05-06 | Injury | None | None |
| 2009-01-01 | Injury | None | None |
| 2008-10-07 | Injury | None | Fracture, Device Dislodged or Dislocated |
| 2008-10-01 | Malfunction | None | Under-Sensing |
| 2008-03-26 | Injury | None | None |
| 2008-01-01 | Malfunction | None | Over-Sensing |
| 2007-08-17 | Injury | None | Device Dislodged or Dislocated |
| 2007-02-07 | Death | None | Fracture, Mechanical Problem, Under-Sensing, Device Dislodged or Dislocated |
| 2007-01-01 | Death | None | Failure to Capture, High impedance, Mechanical Problem, Over-Sensing, Under-Sensing, Low impedance, Device Operates Differently Than Expected, Material Deformation, Appropriate Term/Code Not Available, High Capture Threshold |
| 2007-01-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Dislodged or Dislocated |
| 2007-01-01 | Injury | None | Failure to Capture, Fracture, Cut In Material, Capturing Problem |
| 2006-10-05 | Injury | None | Over-Sensing |
| 2006-10-01 | Injury | None | Collapse, Device Dislodged or Dislocated |
| 2006-08-12 | Malfunction | None | Signal Artifact/Noise |
| 2006-07-01 | Injury | None | Failure to Capture, Pocket Stimulation, High Capture Threshold |
| 2006-05-30 | Injury | None | Under-Sensing, High Capture Threshold |
| 2006-04-12 | Injury | None | Failure to Capture, Fracture, Device Sensing Problem, Device Dislodged or Dislocated, Appropriate Term/Code Not Available, High Capture Threshold |
| 2006-02-13 | Malfunction | None | Decreased Sensitivity |
| 2005-10-29 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2005-09-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2005-09-01 | Injury | None | Unstable Capture Threshold |
| 2005-06-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2005-05-01 | Injury | None | Break, Fracture, Over-Sensing, Impedance Problem, High Capture Threshold |
| 2005-05-01 | Death | None | Break, Fracture, Over-Sensing, Impedance Problem, High Capture Threshold |
| 2005-01-01 | Injury | None | Fracture, Cut In Material, Device Dislodged or Dislocated, High Capture Threshold |
| 2005-01-01 | Malfunction | None | Appropriate Term/Code Not Available |
| 2005-01-01 | Injury | None | Fracture, Device Dislodged or Dislocated |
| 2005-01-01 | Malfunction | None | Over-Sensing |
| 2004-10-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2004-10-01 | Injury | None | Fracture |
| 2004-05-17 | Death | None | Break, Low impedance, High Capture Threshold |
| 2004-01-01 | Injury | None | Failure to Capture, Fracture, Stretched, Cut In Material, Device Dislodged or Dislocated, High Capture Threshold |
| 2004-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2004-01-01 | Injury | None | Fracture, Over-Sensing, Impedance Problem |
| 2003-01-01 | Death | None | Appropriate Term/Code Not Available |
| 2002-01-01 | Injury | None | Device Dislodged or Dislocated, Impedance Problem, High Capture Threshold |
| 2001-04-01 | Death | None | Failure to Capture, Fracture, Under-Sensing |
| 2001-01-12 | Injury | None | Appropriate Term/Code Not Available |
| 2001-01-01 | Death | None | Fracture, Capturing Problem, Device Sensing Problem |
| 2001-01-01 | Malfunction | None | Difficult to Remove, Positioning Problem |
| 2001-01-01 | Injury | None | Intermittent Capture, Under-Sensing, Capturing Problem, Device Operates Differently Than Expected, Positioning Problem, High Capture Threshold, Unstable Capture Threshold |
| 2001-01-01 | Injury | None | Difficult to Remove, Positioning Problem |
| 2000-01-01 | Injury | None | Fracture, Capturing Problem, Device Sensing Problem, Device Dislodged or Dislocated, Unstable Capture Threshold |
| 2000-01-01 | Injury | None | Failure to Capture, Fracture, Over-Sensing, Under-Sensing, Capturing Problem |
| 2000-01-01 | Injury | None | Failure to Sense, Capturing Problem, Unstable Capture Threshold |
| 1998-10-20 | Death | None | Mechanical Problem |