DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
This device is manufactured by MEDTRONIC, MEDTRONIC PUERTO RICO OPERATIONS CO.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-04-26 | Death | Fall, Renal Failure, Sepsis, Hypovolemia, Cardiogenic Shock, Hyperkalemia | Adverse Event Without Identified Device or Use Problem |
| 2024-02-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Battery Problem |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-10-13 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-13 | Injury | Shock from Patient Lead(s) | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2023-08-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Battery Problem |
| 2023-08-08 | Injury | Endocarditis, Fatigue, Unspecified Infection, Sepsis, Chills, Bacteremia | Adverse Event Without Identified Device or Use Problem |
| 2023-07-14 | Injury | Tachycardia | Failure to Deliver Shock/Stimulation |
| 2023-07-11 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Interrogate, Pacing Problem, Appropriate Term/Code Not Available |
| 2023-06-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pacing Problem, Device Sensing Problem |
| 2023-06-07 | Injury | Unspecified Infection, Drug Resistant Bacterial Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-05-23 | Malfunction | Fatigue, Muscle Weakness/Atrophy | Appropriate Term/Code Not Available |
| 2022-11-28 | Injury | None | Mechanical Problem, Misconnection, Component Missing |
| 2022-10-17 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2022-10-06 | Injury | None | Failure to Charge |
| 2022-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-07 | Injury | None | Failure to Deliver Shock/Stimulation |
| 2022-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-17 | Malfunction | None | Signal Artifact/Noise, Electromagnetic Interference, Over-Sensing |
| 2022-07-04 | Injury | None | Failure to Charge, Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2022-04-05 | Injury | None | Premature Discharge of Battery |
| 2022-04-01 | Injury | None | Premature Discharge of Battery |
| 2022-03-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-25 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-16 | Injury | None | Device Sensing Problem |
| 2022-03-14 | Malfunction | None | Battery Problem |
| 2022-03-12 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2022-01-18 | Malfunction | Failure of Implant | Premature Discharge of Battery |
| 2021-10-21 | Death | Appropriate Term / Code Not Available | Battery Problem |
| 2021-09-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-07-07 | Injury | Unspecified Infection | Insufficient Information |
| 2021-06-16 | Injury | Unspecified Infection | Insufficient Information |
| 2021-06-16 | Injury | Unspecified Infection | Insufficient Information |
| 2021-03-08 | Malfunction | Insufficient Information | Premature Discharge of Battery |
| 2019-09-10 | Injury | None | Premature Discharge of Battery |
| 2019-08-30 | Injury | None | Premature Discharge of Battery |
| 2019-08-29 | Injury | None | Device Sensing Problem |
| 2019-08-27 | Injury | None | Premature Discharge of Battery |
| 2019-08-27 | Injury | None | Premature Discharge of Battery |
| 2019-08-20 | Injury | None | Premature Discharge of Battery |
| 2019-08-17 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-08-13 | Malfunction | None | Incorrect Measurement, Unable to Obtain Readings |
| 2019-08-13 | Injury | None | Premature Discharge of Battery |
| 2019-08-12 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-08-10 | Injury | None | Reset Problem |
| 2019-08-07 | Injury | None | Migration or Expulsion of Device |
| 2019-08-07 | Injury | None | Premature Discharge of Battery |
| 2019-08-07 | Injury | None | Premature Discharge of Battery |
| 2019-08-06 | Injury | None | Electromagnetic Interference, Pacing Problem |
| 2019-07-30 | Injury | None | Premature Discharge of Battery |
| 2019-07-25 | Malfunction | None | Unable to Obtain Readings, Output Problem |
| 2019-07-25 | Injury | None | Premature Discharge of Battery |
| 2019-07-19 | Injury | None | Premature Discharge of Battery |
| 2019-07-17 | Injury | None | Premature Discharge of Battery |
| 2019-07-16 | Injury | None | Signal Artifact/Noise, Electromagnetic Interference, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2019-07-10 | Malfunction | None | Pacing Problem |
| 2019-07-02 | Injury | None | Premature Discharge of Battery |
| 2019-07-02 | Injury | None | Premature Discharge of Battery |
| 2019-06-30 | Injury | None | Pacing Problem, Device Sensing Problem |
| 2019-06-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-25 | Injury | None | Premature Discharge of Battery |
| 2019-06-24 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-06-22 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-18 | Injury | None | Failure to Deliver Shock/Stimulation, Device Sensing Problem |
| 2019-06-14 | Malfunction | None | Unable to Obtain Readings |
| 2019-06-12 | Injury | None | Premature Discharge of Battery |
| 2019-06-10 | Injury | None | Premature Discharge of Battery |
| 2019-06-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-01 | Malfunction | None | Appropriate Term/Code Not Available |
| 2019-05-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-30 | Injury | None | Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2019-05-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-29 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-05-28 | Malfunction | None | Over-Sensing |
| 2019-05-24 | Injury | None | Premature Discharge of Battery |
| 2019-05-23 | Malfunction | None | Electromagnetic Interference |
| 2019-05-20 | Injury | None | Premature Discharge of Battery |
| 2019-05-17 | Injury | None | Premature Discharge of Battery, Output above Specifications |
| 2019-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-15 | Malfunction | None | Premature Discharge of Battery |
| 2019-05-14 | Injury | None | Electrical /Electronic Property Problem, Reset Problem |
| 2019-05-13 | Injury | None | Pacing Problem |
| 2019-05-13 | Malfunction | None | Over-Sensing |
| 2019-05-10 | Injury | 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 | Unable to Obtain Readings |
| 2019-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-29 | Injury | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-04-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-26 | Injury | None | Premature Discharge of Battery |
| 2019-04-24 | Malfunction | None | Premature Discharge of Battery |
| 2019-04-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-22 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-04-20 | Injury | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-04-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-14 | Injury | None | Premature Discharge of Battery |
| 2019-04-12 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-04-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-03 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-04-02 | Injury | None | Premature Discharge of Battery |
| 2019-04-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-02 | Malfunction | None | Premature Discharge of Battery |
| 2019-04-01 | Malfunction | None | Premature Discharge of Battery |
| 2019-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-19 | Injury | None | Premature Discharge of Battery, Low impedance |
| 2019-03-18 | Malfunction | None | Pacing Problem |
| 2019-03-14 | Injury | None | Premature Discharge of Battery |
| 2019-03-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-12 | Injury | None | Premature Discharge of Battery |
| 2019-03-10 | Injury | None | Premature Discharge of Battery |
| 2019-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-06 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-03-04 | Injury | None | Mechanical Problem |
| 2019-02-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-24 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-02-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-15 | Injury | None | Premature Discharge of Battery |
| 2019-02-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-05 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-02-04 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-02-03 | Injury | None | Capturing Problem |
| 2019-02-01 | Malfunction | None | Unable to Obtain Readings |
| 2019-02-01 | Injury | None | Premature Discharge of Battery |
| 2019-01-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-25 | Injury | None | Premature Discharge of Battery |
| 2019-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-23 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-01-22 | Injury | None | Device Sensing Problem |
| 2019-01-21 | Injury | None | Appropriate Term/Code Not Available |
| 2019-01-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-16 | Injury | None | Premature Discharge of Battery |
| 2019-01-14 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-01-11 | Injury | None | Premature Discharge of Battery |
| 2019-01-11 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-01-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-06 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-01-04 | Malfunction | None | Signal Artifact/Noise, Electromagnetic Interference, Over-Sensing |
| 2019-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-01 | Injury | None | Premature Discharge of Battery |
| 2019-01-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-12-27 | Injury | None | Premature Discharge of Battery |
| 2018-12-25 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2018-12-16 | Injury | None | Failure to Charge |
| 2018-12-10 | Injury | None | Premature Discharge of Battery |
| 2018-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-06 | Injury | None | Premature Discharge of Battery |
| 2018-12-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-01 | Injury | None | Signal Artifact/Noise, Electromagnetic Interference, Over-Sensing |
| 2018-11-28 | Injury | None | Premature Discharge of Battery |
| 2018-11-26 | Injury | None | Premature Discharge of Battery |
| 2018-11-26 | Injury | None | Premature Discharge of Battery |
| 2018-11-20 | Injury | None | Premature Discharge of Battery |
| 2018-11-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-19 | Malfunction | None | Premature Discharge of Battery |
| 2018-11-09 | Injury | None | Premature Discharge of Battery |
| 2018-11-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-08 | Injury | None | Premature Discharge of Battery |
| 2018-10-31 | Injury | None | Mechanical Problem, Under-Sensing |
| 2018-10-30 | Malfunction | None | Battery Problem |
| 2018-10-29 | Injury | None | Premature Discharge of Battery |
| 2018-10-29 | Malfunction | None | Mechanical Problem |
| 2018-10-26 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-10-24 | Injury | None | Mechanical Problem |
| 2018-10-22 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2018-10-22 | Malfunction | None | Signal Artifact/Noise, Electromagnetic Interference, Adverse Event Without Identified Device or Use Problem |
| 2018-10-17 | Malfunction | Insufficient Information | Over-Sensing, Incorrect Interpretation of Signal |
| 2018-10-16 | Malfunction | None | Signal Artifact/Noise, Electromagnetic Interference, Mechanical Problem, Over-Sensing |
| 2018-10-16 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-16 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2018-10-15 | Malfunction | None | Premature Discharge of Battery |
| 2018-10-14 | Injury | None | Premature Discharge of Battery, Battery Problem, Reset Problem |
| 2018-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-06 | Injury | None | Device Sensing Problem |
| 2018-10-05 | Malfunction | None | Premature Discharge of Battery |
| 2018-10-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-26 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2018-09-26 | Death | None | Appropriate Term/Code Not Available |
| 2018-09-19 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-09-19 | Injury | None | Premature Discharge of Battery |
| 2018-09-17 | Malfunction | None | Over-Sensing |
| 2018-09-17 | Injury | None | Mechanical Problem |
| 2018-09-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-14 | Malfunction | None | Signal Artifact/Noise, Electromagnetic Interference, Over-Sensing, Pacing Problem |
| 2018-09-14 | Malfunction | None | Failure to Capture, Mechanical Problem, Misconnection |
| 2018-09-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-06 | Injury | None | Premature Discharge of Battery |
| 2018-09-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-01 | Injury | None | Over-Sensing, Pacing Problem |
| 2018-09-01 | Malfunction | None | Battery Problem |
| 2018-08-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-27 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-27 | Injury | None | Premature Discharge of Battery |
| 2018-08-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-23 | Injury | None | Premature Discharge of Battery |
| 2018-08-23 | Injury | None | Premature Discharge of Battery |
| 2018-08-21 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-08-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-13 | Malfunction | None | Device Sensing Problem |
| 2018-08-10 | Injury | None | Premature Discharge of Battery |
| 2018-08-09 | Death | None | Device Sensing Problem |
| 2018-07-30 | Malfunction | None | Device Sensing Problem |
| 2018-07-27 | Injury | None | Premature Discharge of Battery |
| 2018-07-27 | Malfunction | None | Over-Sensing |
| 2018-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-26 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2018-07-25 | Injury | None | Unable to Obtain Readings |
| 2018-07-23 | Injury | None | Pacing Problem |
| 2018-07-18 | Death | None | Under-Sensing |
| 2018-07-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-14 | Injury | None | Over-Sensing |
| 2018-07-14 | Injury | None | Fracture, Mechanical Problem |
| 2018-07-13 | Injury | None | Premature Discharge of Battery |
| 2018-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-11 | Injury | None | Migration or Expulsion of Device, Material Protrusion/Extrusion, Adverse Event Without Identified Device or Use Problem |
| 2018-07-10 | Malfunction | None | Premature Discharge of Battery, Low impedance, High Capture Threshold |
| 2018-07-10 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2018-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-06 | Injury | None | Material Erosion |
| 2018-07-05 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Under-Sensing, Device Sensing Problem |
| 2018-07-05 | Injury | None | Premature Discharge of Battery |
| 2018-07-05 | Malfunction | None | Failure to Interrogate, Application Program Freezes, Becomes Nonfunctional |
| 2018-06-30 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2018-06-29 | Malfunction | None | Premature Discharge of Battery |
| 2018-06-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-22 | Injury | None | Grounding Malfunction, Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2018-06-22 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-06-20 | Malfunction | None | Premature Discharge of Battery |
| 2018-06-18 | Injury | None | Capturing Problem |
| 2018-06-18 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-14 | Injury | None | Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available |
| 2018-06-14 | Injury | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2018-06-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-06 | Injury | None | Premature Discharge of Battery |
| 2018-06-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-03 | Injury | None | Invalid Sensing |
| 2018-06-01 | Malfunction | None | Premature Discharge of Battery |
| 2018-05-30 | Injury | None | Invalid Sensing |
| 2018-05-29 | Injury | None | Invalid Sensing |
| 2018-05-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-22 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-05-18 | Malfunction | None | Display or Visual Feedback Problem, Electromagnetic Interference, Over-Sensing |
| 2018-05-17 | Injury | None | Data Problem |
| 2018-05-16 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-05-15 | Injury | None | Premature Discharge of Battery |
| 2018-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-08 | Injury | None | Premature Discharge of Battery |
| 2018-05-07 | Malfunction | None | Pacing Problem |
| 2018-05-04 | Malfunction | None | Communication or Transmission Problem |
| 2018-05-02 | Injury | None | Device Operates Differently Than Expected |
| 2018-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-02 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-04-28 | Injury | None | Premature Discharge of Battery |
| 2018-04-26 | Injury | None | Premature Discharge of Battery |
| 2018-04-26 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-24 | Injury | None | Premature Discharge of Battery |
| 2018-04-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-20 | Malfunction | None | Pacing 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 |
| 2018-04-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-18 | Injury | None | Premature Discharge of Battery |
| 2018-04-18 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-04-18 | Injury | None | Premature Discharge of Battery |
| 2018-04-17 | Malfunction | None | Pacing Problem |
| 2018-04-14 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-04-13 | Malfunction | None | Premature Discharge of Battery |
| 2018-04-12 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-04-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-10 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-04-10 | Injury | None | Pacing Problem |
| 2018-04-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-02 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-04-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-01 | Malfunction | None | Pacing Problem |
| 2018-04-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-04-01 | Malfunction | None | Over-Sensing |
| 2018-03-31 | Malfunction | None | Over-Sensing |
| 2018-03-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-28 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-24 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-22 | Injury | None | Premature Discharge of Battery |
| 2018-03-20 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-03-20 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-03-19 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-03-17 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-03-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-16 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-03-13 | Malfunction | None | Battery Problem |
| 2018-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-07 | Death | None | Defibrillation/Stimulation Problem |
| 2018-03-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-06 | Malfunction | None | Over-Sensing |
| 2018-03-05 | Injury | None | Premature Discharge of Battery |
| 2018-03-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-28 | Injury | None | Premature Discharge of Battery |
| 2018-02-28 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-02-27 | Injury | None | Premature Discharge of Battery |
| 2018-02-26 | Injury | None | Incorrect Measurement, Unable to Obtain Readings |
| 2018-02-26 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-02-23 | Malfunction | None | Battery Problem |
| 2018-02-21 | Malfunction | None | Incorrect Measurement |
| 2018-02-20 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-02-19 | Injury | None | Mechanical Problem |
| 2018-02-16 | Malfunction | None | Failure to Interrogate |
| 2018-02-13 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-02-13 | Malfunction | None | Unable to Obtain Readings |
| 2018-02-12 | Injury | None | Premature Discharge of Battery |
| 2018-02-12 | Injury | None | Battery Problem |
| 2018-02-08 | Injury | None | Premature Discharge of Battery |
| 2018-02-08 | Malfunction | None | Failure to Interrogate |
| 2018-02-07 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-02-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-02 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-01-30 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-30 | Death | None | Under-Sensing, Invalid Sensing |
| 2018-01-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-26 | Injury | None | Defibrillation/Stimulation Problem, Battery Problem |
| 2018-01-26 | Injury | None | Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-01-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-24 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-23 | Injury | None | Premature Discharge of Battery |
| 2018-01-19 | Malfunction | None | Over-Sensing |
| 2018-01-18 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-17 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-17 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-12 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-01-11 | Malfunction | None | Battery Problem |
| 2018-01-10 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-10 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-10 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-10 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-01-10 | Injury | None | Premature Discharge of Battery |
| 2018-01-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-09 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-05 | Injury | None | Premature Discharge of Battery |
| 2018-01-04 | Injury | None | Premature Discharge of Battery |
| 2018-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-02 | Injury | None | Premature Discharge of Battery |
| 2018-01-02 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2018-01-02 | Malfunction | None | Premature Discharge of Battery |
| 2018-01-02 | Injury | None | Premature Discharge of Battery |
| 2018-01-02 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-12-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-27 | Injury | None | Premature Discharge of Battery |
| 2017-12-27 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-12-22 | Malfunction | None | Pacing Problem |
| 2017-12-21 | Malfunction | None | Pacing Problem |
| 2017-12-18 | Malfunction | None | Invalid Sensing |
| 2017-12-12 | Malfunction | None | Communication or Transmission Problem |
| 2017-12-11 | Malfunction | None | Premature Discharge of Battery |
| 2017-12-11 | Malfunction | None | Incorrect Measurement, Unable to Obtain Readings |
| 2017-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-05 | Injury | None | Defibrillation/Stimulation Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-12-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-12-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-11-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-28 | Injury | None | Premature Discharge of Battery |
| 2017-11-27 | Death | None | Appropriate Term/Code Not Available |
| 2017-11-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-22 | Malfunction | None | Failure to Interrogate |
| 2017-11-20 | Injury | None | Premature Discharge of Battery |
| 2017-11-18 | Death | None | Device Operates Differently Than Expected |
| 2017-11-15 | Malfunction | None | Failure to Interrogate |
| 2017-11-14 | Malfunction | None | Appropriate Term/Code Not Available |
| 2017-11-09 | Injury | None | Premature Discharge of Battery |
| 2017-11-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-31 | Malfunction | None | Premature Discharge of Battery |
| 2017-10-29 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-10-29 | Injury | None | Premature Discharge of Battery |
| 2017-10-20 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-10-19 | Malfunction | None | Premature Discharge of Battery, Battery Problem |
| 2017-10-11 | Malfunction | None | Misconnection |
| 2017-10-11 | Injury | None | Premature Discharge of Battery |
| 2017-10-09 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-10-09 | Injury | None | Premature Discharge of Battery |
| 2017-10-06 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-05 | Injury | None | Appropriate Term/Code Not Available |
| 2017-10-03 | Injury | None | Pacing Problem |
| 2017-09-29 | Injury | None | Failure to Capture, Mechanical Problem, Decreased Sensitivity, High Capture Threshold |
| 2017-09-26 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-09-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-23 | Injury | None | Premature Discharge of Battery, Failure to Interrogate, Pacing Problem |
| 2017-09-20 | Injury | None | Premature Discharge of Battery |
| 2017-09-20 | Injury | None | Invalid Sensing, Device Sensing Problem |
| 2017-09-20 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2017-09-20 | Malfunction | None | Battery Problem |
| 2017-09-20 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-19 | Malfunction | None | Mechanical Problem |
| 2017-09-13 | Malfunction | None | Pacing Problem |
| 2017-09-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-31 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2017-08-30 | Malfunction | None | Unable to Obtain Readings |
| 2017-08-28 | Injury | None | Mechanical Problem |
| 2017-08-28 | Malfunction | None | Defibrillation/Stimulation Problem |
| 2017-08-26 | Death | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-08-25 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-08-18 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-08-14 | Injury | None | Premature Discharge of Battery |
| 2017-08-12 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-08-02 | Malfunction | None | Pacing Problem |
| 2017-07-31 | Malfunction | None | Reset Problem |
| 2017-07-27 | Injury | None | Premature Discharge of Battery |
| 2017-07-24 | Malfunction | None | High impedance, Mechanical Problem, Misconnection |
| 2017-07-22 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2017-07-17 | Malfunction | None | Pacing Problem |
| 2017-07-11 | Injury | None | Premature Discharge of Battery |
| 2017-07-01 | Death | None | Pacing Problem |
| 2017-06-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-24 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-06-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-19 | Injury | None | Device Operates Differently Than Expected |
| 2017-06-15 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-06-15 | Malfunction | None | Mechanical Problem |
| 2017-06-14 | Malfunction | None | High impedance, Mechanical Problem |
| 2017-06-13 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-06-09 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-06-07 | Injury | None | Invalid Sensing |
| 2017-06-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-30 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2017-05-25 | Injury | None | Invalid Sensing |
| 2017-05-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-17 | Injury | None | Invalid Sensing |
| 2017-05-14 | Death | None | Protective Measures Problem |
| 2017-05-09 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-05-08 | Malfunction | None | Impedance Problem, Protective Measures Problem |
| 2017-05-06 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-05-06 | Death | None | Pacing Problem |
| 2017-05-02 | Malfunction | None | Pacing Problem |
| 2017-04-28 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-04-28 | Injury | None | Premature Discharge of Battery |
| 2017-04-23 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-19 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-04-14 | Injury | None | Premature Discharge of Battery |
| 2017-04-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-12 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-04-06 | Injury | None | Premature Discharge of Battery |
| 2017-04-05 | Malfunction | None | Pacing Problem |
| 2017-04-02 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-04-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-03-31 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-28 | Injury | None | Premature Discharge of Battery, Over-Sensing, Pacing Problem |
| 2017-03-27 | Injury | None | Invalid Sensing |
| 2017-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-24 | Injury | None | Premature Discharge of Battery |
| 2017-03-22 | Injury | None | Mechanical Problem |
| 2017-03-19 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-03-16 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-03-16 | Injury | None | Pacing Problem |
| 2017-03-09 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-06 | Injury | None | Migration or Expulsion of Device |
| 2017-03-06 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-01 | Malfunction | None | Unable to Obtain Readings, Device Displays Incorrect Message |
| 2017-02-28 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-27 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-27 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-23 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-22 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2017-02-21 | Malfunction | None | Incorrect Measurement |
| 2017-02-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-21 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-20 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-20 | Injury | None | Premature Discharge of Battery |
| 2017-02-18 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-13 | Malfunction | None | Migration or Expulsion of Device |
| 2017-02-13 | Malfunction | None | Electrical /Electronic Property Problem, Failure to Interrogate |
| 2017-02-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-07 | Malfunction | None | High impedance |
| 2017-02-06 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-06 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-02-03 | Malfunction | None | Break |
| 2017-01-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-27 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-01-26 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-01-26 | Malfunction | None | Premature Discharge of Battery, Electrical /Electronic Property Problem |
| 2017-01-26 | Injury | None | Premature Discharge of Battery |
| 2017-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-24 | Malfunction | None | High impedance, Misconnection |
| 2017-01-23 | Injury | None | Premature Discharge of Battery |
| 2017-01-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-18 | Malfunction | None | Premature Discharge of Battery, Missing Test Results |
| 2017-01-13 | Malfunction | Insufficient Information | Use of Device Problem |
| 2017-01-13 | Malfunction | None | Device Expiration Issue |
| 2017-01-12 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2017-01-12 | Injury | None | Migration or Expulsion of Device |
| 2017-01-10 | Malfunction | None | Over-Sensing |
| 2017-01-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-02 | Injury | None | Premature Discharge of Battery |
| 2017-01-01 | Injury | None | Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing, Output Problem |
| 2017-01-01 | Injury | None | Premature Discharge of Battery |
| 2017-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-30 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-12-28 | Injury | None | Migration or Expulsion of Device |
| 2016-12-27 | Malfunction | None | Over-Sensing |
| 2016-12-24 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-12-24 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-12-22 | Malfunction | None | Misconnection |
| 2016-12-22 | Malfunction | None | Misconnection |
| 2016-12-22 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-12-20 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-12-18 | Malfunction | None | Pacing Problem |
| 2016-12-15 | Malfunction | None | Mechanical Problem |
| 2016-12-15 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-12-12 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2016-12-11 | Malfunction | None | Failure to Convert Rhythm |
| 2016-12-09 | Malfunction | None | Misconnection |
| 2016-12-07 | Malfunction | None | Mechanical Problem, Misconnection, Device Sensing Problem |
| 2016-12-06 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-12-05 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-26 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-11-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-18 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-11-17 | Malfunction | None | Mechanical Problem |
| 2016-11-14 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-11-12 | Malfunction | None | Invalid Sensing, Device Sensing Problem |
| 2016-11-12 | Death | None | Defibrillation/Stimulation Problem |
| 2016-11-11 | Malfunction | None | High impedance, Misconnection |
| 2016-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2016-10-31 | Malfunction | None | Premature Discharge of Battery |
| 2016-10-28 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-17 | Injury | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2016-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-15 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-10-14 | Injury | None | Pacing Problem |
| 2016-10-14 | Injury | None | Electrical /Electronic Property Problem |
| 2016-10-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-07 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-10-07 | Injury | None | Premature Discharge of Battery |
| 2016-10-05 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2016-10-01 | Injury | None | Premature Discharge of Battery |
| 2016-10-01 | Death | None | Electrical /Electronic Property Problem |
| 2016-10-01 | Malfunction | None | Mechanical Problem |
| 2016-09-30 | Malfunction | None | Mechanical Problem |
| 2016-09-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-29 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-09-26 | Malfunction | None | Mechanical Problem, Device Damaged by Another Device |
| 2016-09-26 | Injury | None | Premature Discharge of Battery |
| 2016-09-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-19 | Injury | None | Invalid Sensing |
| 2016-09-17 | Injury | None | Failure to Convert Rhythm |
| 2016-09-14 | Malfunction | None | Mechanical Problem, Misconnection, Over-Sensing, Impedance Problem |
| 2016-09-13 | Injury | None | Appropriate Term/Code Not Available |
| 2016-09-13 | Injury | None | Failure to Capture, High impedance, Mechanical Problem, Misconnection |
| 2016-09-09 | Malfunction | None | Mechanical Problem, Impedance Problem |
| 2016-09-09 | Malfunction | None | Failure to Convert Rhythm |
| 2016-09-09 | Malfunction | None | Failure to Interrogate |
| 2016-09-08 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2016-09-07 | Injury | None | Premature Discharge of Battery |
| 2016-09-07 | Malfunction | None | Mechanical Problem |
| 2016-09-06 | Malfunction | None | Protective Measures Problem |
| 2016-09-02 | Injury | None | Intermittent Capture, Failure to Capture, Capturing Problem, Unstable Capture Threshold |
| 2016-08-30 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-08-29 | Injury | None | Premature Discharge of Battery, Device Sensing Problem |
| 2016-08-27 | Injury | None | Invalid Sensing |
| 2016-08-27 | Injury | None | High impedance, Mechanical Problem |
| 2016-08-26 | Malfunction | None | Mechanical Problem, Impedance Problem |
| 2016-08-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-21 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-08-19 | Malfunction | None | Defibrillation/Stimulation Problem |
| 2016-08-17 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-16 | Injury | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Under-Sensing |
| 2016-08-15 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-08-10 | Injury | None | Premature Discharge of Battery |
| 2016-08-10 | Death | None | Invalid Sensing |
| 2016-08-09 | Injury | None | Premature Discharge of Battery |
| 2016-08-08 | Malfunction | None | Pacing Problem |
| 2016-08-04 | Malfunction | None | Mechanical Problem |
| 2016-08-04 | Injury | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2016-08-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-03 | Malfunction | None | Pacing Problem |
| 2016-08-03 | Malfunction | None | Mechanical Problem |
| 2016-08-01 | Injury | None | Failure to Capture, Over-Sensing |
| 2016-08-01 | Injury | None | Pacing Problem |
| 2016-08-01 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-07-26 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2016-07-22 | Malfunction | None | Pacing Problem |
| 2016-07-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-21 | Injury | None | Premature Discharge of Battery |
| 2016-07-19 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2016-07-18 | Injury | None | Premature Discharge of Battery |
| 2016-07-17 | Injury | None | Premature Discharge of Battery |
| 2016-07-15 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-07-14 | Malfunction | None | High impedance, Mechanical Problem, Device Damaged by Another Device |
| 2016-07-14 | Malfunction | None | Pacing Problem |
| 2016-07-13 | Malfunction | None | Mechanical Problem |
| 2016-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-07 | Malfunction | None | Over-Sensing |
| 2016-07-01 | Death | None | Misconnection |
| 2016-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-29 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-06-28 | Injury | None | Invalid Sensing |
| 2016-06-27 | Malfunction | None | High impedance, Mechanical Problem |
| 2016-06-26 | Injury | None | Mechanical Problem |
| 2016-06-25 | Malfunction | None | Pacing Problem |
| 2016-06-23 | Malfunction | None | Appropriate Term/Code Not Available |
| 2016-06-20 | Malfunction | None | Mechanical Problem |
| 2016-06-17 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-06-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-13 | Malfunction | None | Mechanical Problem |
| 2016-06-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-12 | Injury | None | Electrical /Electronic Property Problem |
| 2016-06-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-10 | Injury | None | Mechanical Problem |
| 2016-06-10 | Injury | None | Migration or Expulsion of Device |
| 2016-06-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-09 | Malfunction | None | High impedance, Mechanical Problem, Over-Sensing |
| 2016-06-06 | Malfunction | None | Migration or Expulsion of Device |
| 2016-06-06 | Malfunction | None | Component Missing |
| 2016-06-03 | Malfunction | None | Signal Artifact/Noise, Mechanical Problem |
| 2016-06-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-05-31 | Malfunction | None | Mechanical Problem |
| 2016-05-26 | Malfunction | None | Over-Sensing |
| 2016-05-26 | Injury | None | Mechanical Problem |
| 2016-05-26 | Malfunction | None | Over-Sensing |
| 2016-05-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-23 | Injury | None | False Alarm |
| 2016-05-23 | Injury | None | Failure to Capture, Mechanical Problem |
| 2016-05-23 | Malfunction | None | Failure to Interrogate |
| 2016-05-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-20 | Injury | None | Migration or Expulsion of Device |
| 2016-05-20 | Injury | None | Defibrillation/Stimulation Problem |
| 2016-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-17 | Malfunction | None | Mechanical Problem |
| 2016-05-16 | Malfunction | None | Battery Problem |
| 2016-05-16 | Malfunction | None | Mechanical Problem, Over-Sensing |
| 2016-05-16 | Injury | None | Premature Discharge of Battery |
| 2016-05-14 | Injury | None | Defibrillation/Stimulation Problem, Invalid Sensing |
| 2016-05-13 | Injury | None | Appropriate Term/Code Not Available |
| 2016-05-13 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2016-05-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-05-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-08 | Malfunction | None | Defibrillation/Stimulation Problem, Invalid Sensing |
| 2016-05-06 | Injury | None | Electromagnetic Interference, Over-Sensing |
| 2016-05-05 | Injury | None | Mechanical Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2016-05-04 | Malfunction | None | Battery Problem |
| 2016-05-03 | Malfunction | None | Battery Problem |
| 2016-05-01 | Malfunction | None | False Alarm, Electromagnetic Interference, Over-Sensing |
| 2016-04-28 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Invalid Sensing |
| 2016-04-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-04-19 | Injury | None | Electrical /Electronic Property Problem |
| 2016-04-11 | Injury | None | Invalid Sensing |
| 2016-04-08 | Injury | None | Failure to Capture, Mechanical Problem |
| 2016-04-01 | Malfunction | None | Mechanical Problem |
| 2016-03-22 | Injury | None | Mechanical Problem |
| 2016-03-17 | Injury | None | Mechanical Problem |
| 2016-03-17 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-03-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-03-01 | Injury | None | Pacing Problem, Invalid Sensing |
| 2016-01-26 | Injury | None | Pacing Problem |
| 2016-01-21 | Malfunction | None | Migration or Expulsion of Device |
| 2016-01-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-12 | Injury | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2016-01-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-12-26 | Injury | None | Appropriate Term/Code Not Available |
| 2015-12-15 | Injury | None | Failure to Capture, Over-Sensing |
| 2015-10-24 | Injury | None | Failure to Capture |
| 2015-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-10-06 | Injury | Headache, Nausea, Diaphoresis | Appropriate Term/Code Not Available |
| 2015-09-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-08-13 | Injury | None | Appropriate Term/Code Not Available |
| 2015-08-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-06-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-05-19 | Injury | None | Appropriate Term/Code Not Available |
| 2015-05-06 | Death | None | Failure to Convert Rhythm |
| 2015-04-24 | Death | None | Defibrillation/Stimulation Problem |
| 2015-03-22 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2015-03-09 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2015-03-05 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2015-01-09 | Injury | None | Adverse Event Without Identified Device or Use Problem, Protective Measures Problem |
| 2014-12-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-01 | Injury | None | Misconnection |
| 2013-02-11 | Malfunction | None | None |