IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
This device is manufactured by ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2019-02-21 | Malfunction | None | Vibration |
| 2019-02-11 | Injury | None | Delayed Charge Time |
| 2018-10-17 | Injury | None | Material Protrusion/Extrusion |
| 2017-12-04 | Injury | None | Difficult to Interrogate |
| 2017-05-11 | Injury | None | Premature Discharge of Battery |
| 2016-12-22 | Malfunction | None | Under-Sensing |
| 2016-12-13 | Injury | None | Application Program Problem: Parameter Calculation Error |
| 2016-11-25 | Malfunction | None | Data Problem |
| 2016-10-15 | Injury | None | Connection Problem |
| 2016-10-14 | Malfunction | None | Battery Problem |
| 2016-09-24 | Injury | None | Delayed Charge Time |
| 2016-08-30 | Malfunction | None | High impedance |
| 2016-07-31 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-16 | Injury | None | Premature Discharge of Battery |
| 2016-06-16 | Injury | None | Inappropriate or Unexpected Reset |
| 2016-06-14 | Malfunction | None | Mechanical Problem |
| 2016-04-25 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-12 | Injury | None | Premature Discharge of Battery |
| 2015-09-30 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2015-06-29 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2015-04-23 | Malfunction | None | Over-Sensing |
| 2015-04-21 | Malfunction | None | Premature Discharge of Battery |
| 2015-04-19 | Malfunction | None | Over-Sensing |
| 2015-04-15 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2015-04-13 | Injury | None | Device Operates Differently Than Expected |
| 2015-03-31 | Malfunction | None | Connection Problem |
| 2015-03-27 | Malfunction | None | Alarm Not Visible |
| 2015-03-27 | Malfunction | None | Premature Discharge of Battery |
| 2015-03-25 | Injury | None | Failure to Interrogate |
| 2015-03-24 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2015-03-20 | Malfunction | None | Over-Sensing |
| 2015-03-09 | Malfunction | None | Over-Sensing |
| 2015-03-02 | Injury | None | Over-Sensing |
| 2015-02-24 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2015-02-13 | Injury | None | Premature Elective Replacement Indicator |
| 2015-01-15 | Injury | None | Premature Elective Replacement Indicator |
| 2014-07-29 | Malfunction | Insufficient Information | Noise, Audible |
| 2014-07-29 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2014-07-14 | Malfunction | None | Premature Discharge of Battery, Device Operates Differently Than Expected |
| 2014-06-29 | Malfunction | None | Over-Sensing |
| 2014-06-29 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2014-06-18 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-06-13 | Injury | None | Premature Discharge of Battery |
| 2014-06-11 | Malfunction | None | Over-Sensing |
| 2014-06-04 | Injury | None | High impedance |
| 2014-06-02 | Malfunction | None | Over-Sensing |
| 2014-05-30 | Malfunction | None | Over-Sensing |
| 2014-05-29 | Malfunction | None | Over-Sensing |
| 2014-05-29 | Injury | None | Delayed Charge Time |
| 2014-05-26 | Malfunction | None | Over-Sensing |
| 2014-05-20 | Malfunction | None | Low impedance |
| 2014-05-19 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-05-12 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-05-11 | Malfunction | None | Over-Sensing |
| 2014-05-08 | Injury | None | Premature Elective Replacement Indicator |
| 2014-05-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-06 | Injury | None | Premature Discharge of Battery |
| 2014-05-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-04-28 | Injury | None | Premature Discharge of Battery, Failure to Interrogate, No Device Output |
| 2014-04-26 | Malfunction | None | High impedance |
| 2014-04-24 | Malfunction | None | Connection Problem |
| 2014-04-23 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2014-04-22 | Malfunction | None | Connection Problem |
| 2014-04-21 | Malfunction | None | Data Problem |
| 2014-04-14 | Malfunction | None | Connection Problem |
| 2014-04-12 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2014-04-10 | Injury | None | Premature Discharge of Battery, Failure to Interrogate |
| 2014-04-09 | Malfunction | None | Connection Problem |
| 2014-04-09 | Injury | None | Premature Elective Replacement Indicator |
| 2014-04-08 | Malfunction | None | Over-Sensing |
| 2014-04-08 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-04-03 | Injury | None | Premature End-of-Life Indicator |
| 2014-04-01 | Malfunction | None | High impedance |
| 2014-04-01 | Injury | None | High impedance |
| 2014-03-31 | Malfunction | None | Aborted Charge |
| 2014-03-31 | Malfunction | None | Connection Problem |
| 2014-03-27 | Injury | None | Failure to Interrogate, Pacing Problem |
| 2014-03-27 | Malfunction | None | Connection Problem |
| 2014-03-25 | Injury | None | Device Operates Differently Than Expected |
| 2014-03-24 | Malfunction | None | Connection Problem |
| 2014-03-24 | Malfunction | None | Connection Problem |
| 2014-03-19 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-03-18 | Malfunction | None | Under-Sensing |
| 2014-03-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-03-14 | Injury | None | Premature Elective Replacement Indicator |
| 2014-03-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-03-12 | Injury | None | Failure to Interrogate |
| 2014-03-12 | Injury | None | Under-Sensing |
| 2014-03-12 | Malfunction | None | Over-Sensing |
| 2014-03-11 | Death | None | Failure to Capture, Inappropriate or Unexpected Reset |
| 2014-03-06 | Injury | None | Failure to Interrogate, Premature Elective Replacement Indicator |
| 2014-03-05 | Malfunction | None | Connection Problem |
| 2014-03-04 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-03-03 | Injury | None | Delayed Charge Time |
| 2014-03-02 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-03-01 | Malfunction | None | Over-Sensing |
| 2014-02-27 | Injury | None | Premature Discharge of Battery |
| 2014-02-27 | Injury | None | Premature Elective Replacement Indicator |
| 2014-02-26 | Malfunction | None | Under-Sensing |
| 2014-02-21 | Injury | None | Premature Elective Replacement Indicator |
| 2014-02-18 | Injury | None | Premature Elective Replacement Indicator |
| 2014-02-18 | Malfunction | None | Connection Problem |
| 2014-02-14 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2014-02-11 | Malfunction | None | Over-Sensing |
| 2014-02-11 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Under-Sensing |
| 2014-01-31 | Injury | None | Premature Discharge of Battery, Failure to Interrogate, Pacing Problem |
| 2014-01-29 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-01-22 | Malfunction | None | Connection Problem |
| 2014-01-20 | Malfunction | None | Over-Sensing |
| 2014-01-14 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-13 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-01-09 | Malfunction | None | Connection Problem |
| 2014-01-09 | Injury | None | Failure to Interrogate |
| 2014-01-07 | Malfunction | None | Over-Sensing |
| 2014-01-06 | Malfunction | None | Under-Sensing |
| 2014-01-06 | Injury | None | Over-Sensing |
| 2014-01-02 | Injury | None | High impedance |
| 2013-12-30 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2013-12-30 | Injury | None | Failure to Interrogate |
| 2013-12-29 | Injury | None | Premature Elective Replacement Indicator |
| 2013-12-27 | Injury | None | Premature End-of-Life Indicator |
| 2013-12-26 | Malfunction | None | Electromagnetic Interference, Over-Sensing |
| 2013-12-23 | Injury | None | Delayed Charge Time |
| 2013-12-23 | Malfunction | None | Over-Sensing |
| 2013-12-19 | Malfunction | None | Over-Sensing |
| 2013-12-19 | Malfunction | None | Over-Sensing |
| 2013-12-17 | Injury | None | Over-Sensing |
| 2013-12-17 | Injury | None | Premature Elective Replacement Indicator |
| 2013-12-16 | Injury | None | Premature End-of-Life Indicator |
| 2013-12-09 | Injury | None | Premature Elective Replacement Indicator |
| 2013-12-09 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2013-12-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-12-08 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2013-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-12-05 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2013-12-04 | Injury | None | Premature Discharge of Battery |
| 2013-12-03 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2013-11-25 | Injury | None | None |
| 2013-11-20 | Injury | None | Premature Discharge of Battery |
| 2013-11-20 | Malfunction | None | Over-Sensing |
| 2013-11-19 | Malfunction | None | None |
| 2013-11-15 | Malfunction | None | None |
| 2013-11-15 | Injury | None | None |
| 2013-11-13 | Malfunction | None | None |
| 2013-11-13 | Injury | None | None |
| 2013-11-12 | Injury | None | Premature Elective Replacement Indicator |
| 2013-11-12 | Death | None | None |
| 2013-11-11 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2013-11-08 | Injury | None | Premature End-of-Life Indicator |
| 2013-11-06 | Injury | None | Delayed Charge Time |
| 2013-11-06 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset, Output Problem |
| 2013-11-06 | Injury | None | Premature Discharge of Battery |
| 2013-10-31 | Malfunction | None | None |
| 2013-10-30 | Injury | None | Premature End-of-Life Indicator, Premature Elective Replacement Indicator |
| 2013-10-30 | Injury | None | Failure to Convert Rhythm |
| 2013-10-29 | Injury | None | None |
| 2013-10-28 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2013-10-25 | Injury | None | None |
| 2013-10-25 | Injury | None | Premature End-of-Life Indicator |
| 2013-10-24 | Malfunction | None | Over-Sensing |
| 2013-10-24 | Injury | None | Premature End-of-Life Indicator |
| 2013-10-23 | Injury | None | Premature Discharge of Battery |
| 2013-10-22 | Injury | None | None |
| 2013-10-22 | Malfunction | None | Over-Sensing |
| 2013-10-16 | Injury | None | Device Operates Differently Than Expected |
| 2013-10-15 | Injury | None | None |
| 2013-10-15 | Death | None | None |
| 2013-10-15 | Injury | None | None |
| 2013-10-15 | Injury | None | None |
| 2013-10-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-10-05 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2013-09-30 | Malfunction | None | None |
| 2013-09-30 | Injury | None | None |
| 2013-09-30 | Injury | None | None |
| 2013-09-26 | Malfunction | None | None |
| 2013-09-26 | Malfunction | None | None |
| 2013-09-26 | Injury | None | None |
| 2013-09-25 | Injury | None | None |
| 2013-09-24 | Malfunction | None | None |
| 2013-09-23 | Injury | None | None |
| 2013-09-20 | Injury | None | None |
| 2013-09-17 | Malfunction | None | None |
| 2013-09-16 | Injury | None | None |
| 2013-09-16 | Malfunction | None | None |
| 2013-09-12 | Injury | None | None |
| 2013-09-10 | Malfunction | None | None |
| 2013-09-05 | Malfunction | None | None |
| 2013-09-05 | Injury | None | None |
| 2013-09-03 | Malfunction | None | None |
| 2013-08-30 | Injury | None | None |
| 2013-08-30 | Malfunction | None | None |
| 2013-08-29 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2013-08-29 | Injury | None | None |
| 2013-08-29 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2013-08-25 | Injury | None | None |
| 2013-08-23 | Injury | None | None |
| 2013-08-23 | Injury | None | None |
| 2013-08-18 | Injury | None | None |
| 2013-08-16 | Death | None | None |
| 2013-08-16 | Malfunction | None | None |
| 2013-08-15 | Injury | None | None |
| 2013-08-15 | Injury | None | None |
| 2013-08-12 | Injury | None | None |
| 2013-08-12 | Malfunction | None | None |
| 2013-08-12 | Injury | None | None |
| 2013-08-12 | Injury | None | None |
| 2013-08-12 | Injury | None | None |
| 2013-08-10 | Injury | None | None |
| 2013-08-09 | Injury | None | None |
| 2013-08-08 | Injury | None | None |
| 2013-08-08 | Malfunction | None | None |
| 2013-08-08 | Malfunction | None | None |
| 2013-08-07 | Injury | None | None |
| 2013-08-06 | Injury | None | None |
| 2013-08-01 | Malfunction | None | None |
| 2013-08-01 | Malfunction | None | None |
| 2013-07-31 | Malfunction | None | None |
| 2013-07-29 | Malfunction | None | None |
| 2013-07-28 | Injury | None | None |
| 2013-07-26 | Injury | None | None |
| 2013-07-24 | Injury | None | None |
| 2013-07-19 | Injury | None | None |
| 2013-07-17 | Malfunction | None | None |
| 2013-07-17 | Injury | None | None |
| 2013-07-16 | Injury | None | None |
| 2013-07-12 | Injury | None | None |
| 2013-07-09 | Malfunction | None | None |
| 2013-07-08 | Injury | None | None |
| 2013-07-05 | Malfunction | None | None |
| 2013-07-05 | Injury | None | None |
| 2013-07-03 | Malfunction | None | None |
| 2013-07-01 | Injury | None | None |
| 2013-07-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-06-28 | Malfunction | None | None |
| 2013-06-26 | Injury | None | None |
| 2013-06-26 | Injury | None | None |
| 2013-06-24 | Injury | None | None |
| 2013-06-21 | Malfunction | None | None |
| 2013-06-21 | Injury | None | None |
| 2013-06-20 | Malfunction | None | None |
| 2013-06-19 | Malfunction | None | None |
| 2013-06-19 | Malfunction | None | None |
| 2013-06-17 | Malfunction | None | None |
| 2013-06-14 | Malfunction | None | None |
| 2013-06-14 | Injury | None | None |
| 2013-06-13 | Injury | None | None |
| 2013-06-13 | Injury | None | None |
| 2013-06-12 | Injury | None | None |
| 2013-06-07 | Malfunction | None | None |
| 2013-06-06 | Malfunction | None | None |
| 2013-06-05 | Injury | None | None |
| 2013-05-29 | Injury | None | None |
| 2013-05-27 | Malfunction | None | None |
| 2013-05-23 | Injury | None | None |
| 2013-05-21 | Injury | None | None |
| 2013-05-21 | Malfunction | None | None |
| 2013-05-17 | Injury | None | None |
| 2013-05-15 | Malfunction | None | None |
| 2013-05-14 | Injury | None | None |
| 2013-05-14 | Injury | None | None |
| 2013-05-07 | Malfunction | None | None |
| 2013-05-07 | Malfunction | None | None |
| 2013-05-05 | Death | None | None |
| 2013-05-03 | Injury | None | None |
| 2013-04-30 | Injury | None | None |
| 2013-04-30 | Malfunction | None | None |
| 2013-04-25 | Malfunction | None | None |
| 2013-04-24 | Injury | None | None |
| 2013-04-23 | Malfunction | None | None |
| 2013-04-15 | Malfunction | None | None |
| 2013-04-12 | Malfunction | None | None |
| 2013-04-10 | Injury | None | None |
| 2013-04-08 | Injury | None | None |
| 2013-04-08 | Injury | None | None |
| 2013-04-07 | Death | None | None |
| 2013-04-05 | Malfunction | None | None |
| 2013-04-05 | Malfunction | None | None |
| 2013-04-02 | Malfunction | None | None |
| 2013-04-01 | Malfunction | None | None |
| 2013-03-28 | Malfunction | None | None |
| 2013-03-28 | Injury | None | None |
| 2013-03-28 | Malfunction | None | None |
| 2013-03-27 | Injury | None | None |
| 2013-03-27 | Injury | None | None |
| 2013-03-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-03-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-03-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-03-19 | Malfunction | None | None |
| 2013-03-15 | Malfunction | None | None |
| 2013-03-15 | Malfunction | None | None |
| 2013-03-15 | Injury | None | None |
| 2013-03-12 | Injury | None | None |
| 2013-03-12 | Malfunction | None | None |
| 2013-03-12 | Malfunction | None | None |
| 2013-03-11 | Injury | None | None |
| 2013-03-10 | Injury | None | None |
| 2013-03-08 | Injury | None | None |
| 2013-03-08 | Injury | None | None |
| 2013-03-04 | Malfunction | None | None |
| 2013-03-04 | Injury | None | None |
| 2013-03-04 | Injury | None | None |
| 2013-02-27 | Malfunction | None | None |
| 2013-02-25 | Malfunction | None | None |
| 2013-02-22 | Injury | None | None |
| 2013-02-21 | Death | None | None |
| 2013-02-18 | Injury | None | None |
| 2013-02-15 | Injury | None | None |
| 2013-02-14 | Injury | None | None |
| 2013-02-14 | Malfunction | None | None |
| 2013-02-14 | Injury | None | None |
| 2013-02-14 | Injury | None | None |
| 2013-02-13 | Injury | None | None |
| 2013-02-08 | Unknown | None | Connection Problem |
| 2013-02-08 | Malfunction | None | None |
| 2013-02-08 | Malfunction | None | None |
| 2013-02-06 | Injury | None | None |
| 2013-02-02 | Injury | None | None |
| 2013-01-30 | Malfunction | None | None |
| 2013-01-30 | Malfunction | None | Over-Sensing |
| 2013-01-28 | Malfunction | None | Over-Sensing |
| 2013-01-24 | Malfunction | None | None |
| 2013-01-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-01-15 | Malfunction | None | Over-Sensing |
| 2013-01-14 | Malfunction | None | Over-Sensing |
| 2013-01-14 | Malfunction | None | None |
| 2013-01-08 | Injury | None | None |
| 2013-01-06 | Malfunction | None | None |
| 2012-12-31 | Injury | None | None |
| 2012-12-23 | Malfunction | None | None |
| 2012-12-21 | Death | None | None |
| 2012-12-19 | Malfunction | None | None |
| 2012-12-11 | Malfunction | None | Over-Sensing |
| 2012-12-04 | Malfunction | None | Over-Sensing |
| 2012-11-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-11-27 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2012-11-15 | Malfunction | None | None |
| 2012-11-14 | Malfunction | None | None |
| 2012-11-14 | Malfunction | None | None |
| 2012-11-06 | Malfunction | None | None |
| 2012-11-06 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2012-10-26 | Injury | None | None |
| 2012-10-18 | Malfunction | None | Over-Sensing |
| 2012-10-17 | Injury | None | None |
| 2012-10-16 | Injury | None | None |
| 2012-10-16 | Malfunction | None | Over-Sensing |
| 2012-10-15 | Malfunction | None | Connection Problem |
| 2012-10-11 | Injury | None | None |
| 2012-10-08 | Malfunction | None | Over-Sensing |
| 2012-10-05 | Malfunction | None | Over-Sensing |
| 2012-09-29 | Malfunction | None | None |
| 2012-09-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-09-25 | Injury | None | None |
| 2012-09-13 | Malfunction | None | Over-Sensing |
| 2012-09-03 | Malfunction | None | None |
| 2012-08-28 | Malfunction | None | None |
| 2012-08-27 | Malfunction | None | None |
| 2012-08-23 | Malfunction | None | None |
| 2012-08-22 | Death | None | None |
| 2012-08-15 | Malfunction | None | Over-Sensing |
| 2012-08-13 | Malfunction | None | Over-Sensing |
| 2012-08-10 | Death | None | None |
| 2012-08-09 | Malfunction | None | None |
| 2012-08-08 | Malfunction | None | None |
| 2012-08-07 | Injury | None | Failure to Convert Rhythm, High Capture Threshold |
| 2012-07-31 | Injury | None | None |
| 2012-07-30 | Malfunction | None | Over-Sensing |
| 2012-07-28 | Death | None | None |
| 2012-07-27 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2012-07-20 | Malfunction | None | None |
| 2012-07-16 | Malfunction | None | Device Displays Incorrect Message |
| 2012-07-16 | Injury | None | Premature Discharge of Battery |
| 2012-07-13 | Malfunction | Insufficient Information | High Capture Threshold |
| 2012-07-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-07-10 | Malfunction | None | None |
| 2012-07-09 | Malfunction | None | None |
| 2012-07-05 | Injury | None | None |
| 2012-07-02 | Malfunction | None | Over-Sensing |
| 2012-06-29 | Injury | None | None |
| 2012-06-28 | Malfunction | None | None |
| 2012-06-28 | Malfunction | None | None |
| 2012-06-25 | Malfunction | None | None |
| 2012-06-22 | Malfunction | None | None |
| 2012-06-21 | Injury | None | None |
| 2012-06-21 | Injury | None | None |
| 2012-06-13 | Injury | None | None |
| 2012-06-12 | Injury | None | None |
| 2012-06-06 | Malfunction | None | Low impedance |
| 2012-06-06 | Injury | None | None |
| 2012-06-06 | Injury | None | None |
| 2012-05-31 | Malfunction | None | None |
| 2012-05-25 | Injury | None | None |
| 2012-05-25 | Malfunction | None | None |
| 2012-05-24 | Injury | None | None |
| 2012-05-21 | Injury | None | None |
| 2012-05-21 | Injury | None | None |
| 2012-05-21 | Malfunction | None | Over-Sensing |
| 2012-05-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-05-17 | Injury | None | None |
| 2012-05-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-05-11 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2012-05-10 | Injury | None | None |
| 2012-05-10 | Malfunction | None | Over-Sensing |
| 2012-05-10 | Malfunction | None | Over-Sensing |
| 2012-05-04 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2012-05-04 | Malfunction | None | None |
| 2012-05-03 | Injury | None | None |
| 2012-05-03 | Malfunction | None | Over-Sensing |
| 2012-05-01 | Injury | None | None |
| 2012-05-01 | Death | None | None |
| 2012-04-29 | Malfunction | None | Device Displays Incorrect Message |
| 2012-04-28 | Death | None | None |
| 2012-04-25 | Malfunction | None | Over-Sensing |
| 2012-04-24 | Malfunction | None | Device Displays Incorrect Message |
| 2012-04-23 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2012-04-20 | Malfunction | None | Failure to Convert Rhythm, Therapeutic or Diagnostic Output Failure |
| 2012-04-16 | Injury | None | None |
| 2012-04-04 | Malfunction | None | Over-Sensing |
| 2012-04-04 | Injury | None | High Capture Threshold |
| 2012-04-02 | Malfunction | None | None |
| 2012-03-31 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2012-03-30 | Injury | None | Inappropriate or Unexpected Reset |
| 2012-03-29 | Malfunction | None | Over-Sensing |
| 2012-03-26 | Injury | None | None |
| 2012-03-14 | Injury | None | None |
| 2012-03-13 | Malfunction | None | Over-Sensing |
| 2012-03-12 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2012-03-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-02-29 | Malfunction | None | Over-Sensing |
| 2012-02-26 | Death | None | None |
| 2012-02-24 | Injury | None | None |
| 2012-02-14 | Malfunction | None | Over-Sensing |
| 2012-02-10 | Injury | None | None |
| 2012-02-06 | Death | None | None |
| 2012-02-03 | Injury | None | None |
| 2012-02-03 | Injury | None | None |
| 2012-02-01 | Injury | None | None |
| 2012-01-31 | Injury | None | None |
| 2012-01-25 | Death | None | None |
| 2012-01-25 | Injury | None | None |
| 2012-01-24 | Malfunction | None | Over-Sensing |
| 2012-01-24 | Malfunction | None | Device Displays Incorrect Message |
| 2012-01-23 | Injury | None | Over-Sensing |
| 2012-01-22 | Injury | None | None |
| 2012-01-19 | Injury | None | None |
| 2012-01-18 | Death | None | None |
| 2012-01-10 | Injury | None | None |
| 2012-01-03 | Death | None | None |
| 2012-01-01 | Injury | None | None |
| 2011-12-31 | Malfunction | None | None |
| 2011-12-29 | Injury | None | None |
| 2011-12-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-12-16 | Death | None | None |
| 2011-12-16 | Malfunction | None | None |
| 2011-12-15 | Injury | None | High impedance |
| 2011-12-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-12-11 | Death | None | None |
| 2011-12-08 | Injury | None | None |
| 2011-12-07 | Injury | None | Premature Discharge of Battery, No Device Output |
| 2011-12-07 | Injury | None | Premature Discharge of Battery |
| 2011-12-06 | Injury | None | Failure to Capture, Failure to Sense, Low impedance |
| 2011-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-12-05 | Death | None | None |
| 2011-12-01 | Injury | None | None |
| 2011-11-25 | Death | None | None |
| 2011-11-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-11-21 | Injury | None | Defibrillation/Stimulation Problem, Low impedance |
| 2011-11-20 | Death | None | None |
| 2011-11-20 | Injury | None | High impedance |
| 2011-11-10 | Injury | None | None |
| 2011-11-09 | Injury | None | None |
| 2011-11-08 | Malfunction | None | High impedance |
| 2011-11-08 | Injury | None | Premature Discharge of Battery |
| 2011-11-08 | Malfunction | None | Telemetry Discrepancy |
| 2011-11-07 | Injury | None | None |
| 2011-11-04 | Malfunction | None | Over-Sensing |
| 2011-11-03 | Malfunction | None | None |
| 2011-11-01 | Malfunction | None | Over-Sensing |
| 2011-10-26 | Malfunction | None | None |
| 2011-10-22 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2011-10-21 | Malfunction | None | Device Displays Incorrect Message |
| 2011-10-18 | Injury | None | Device Operates Differently Than Expected |
| 2011-10-18 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2011-10-11 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2011-10-10 | Injury | None | High impedance, Delayed Charge Time |
| 2011-10-07 | Injury | None | High impedance, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2011-10-05 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2011-10-02 | Injury | None | None |
| 2011-09-26 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2011-09-21 | Malfunction | None | Failure to Interrogate, Device Displays Incorrect Message |
| 2011-09-20 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2011-09-20 | Malfunction | None | Over-Sensing |
| 2011-09-13 | Injury | None | None |
| 2011-09-10 | Injury | None | None |
| 2011-09-09 | Injury | None | Over-Sensing, Under-Sensing |
| 2011-09-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2011-09-09 | Malfunction | None | Over-Sensing |
| 2011-09-01 | Malfunction | Endocarditis | Adverse Event Without Identified Device or Use Problem |
| 2011-09-01 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
| 2011-08-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2011-08-24 | Injury | None | Failure to Interrogate |
| 2011-08-23 | Malfunction | None | Over-Sensing |
| 2011-08-23 | Malfunction | None | Over-Sensing |
| 2011-08-22 | Malfunction | None | None |
| 2011-08-19 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2011-08-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2011-08-17 | Injury | None | None |
| 2011-08-11 | Injury | None | None |
| 2011-08-10 | Malfunction | None | Over-Sensing |
| 2011-08-10 | Death | None | None |
| 2011-08-05 | Malfunction | None | None |
| 2011-07-26 | Injury | None | None |
| 2011-07-15 | Injury | None | None |
| 2011-07-14 | Injury | None | Premature Elective Replacement Indicator |
| 2011-07-07 | Malfunction | None | Over-Sensing |
| 2011-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-06-30 | Injury | None | Over-Sensing |
| 2011-06-29 | Malfunction | None | None |
| 2011-06-28 | Malfunction | None | None |
| 2011-06-27 | Malfunction | None | Over-Sensing |
| 2011-06-27 | Malfunction | None | Over-Sensing |
| 2011-06-22 | Injury | None | None |
| 2011-06-22 | Injury | None | Loose or Intermittent Connection, Impedance Problem |
| 2011-06-17 | Injury | None | Premature Discharge of Battery, Telemetry Discrepancy, Output Problem |
| 2011-06-16 | Injury | None | None |
| 2011-06-15 | Malfunction | None | Mechanical Problem |
| 2011-06-14 | Injury | None | None |
| 2011-06-13 | Malfunction | None | Over-Sensing |
| 2011-06-12 | Injury | None | None |
| 2011-06-08 | Death | None | None |
| 2011-06-06 | Injury | None | Under-Sensing |
| 2011-06-05 | Death | None | None |
| 2011-06-03 | Malfunction | Insufficient Information | Battery Problem |
| 2011-06-03 | Malfunction | Insufficient Information | Battery Problem |
| 2011-06-03 | Malfunction | Insufficient Information | Product Quality Problem |
| 2011-06-02 | Injury | None | None |
| 2011-05-31 | Injury | None | None |
| 2011-05-30 | Death | None | None |
| 2011-05-27 | Malfunction | None | Over-Sensing |
| 2011-05-27 | Malfunction | None | None |
| 2011-05-23 | Injury | None | None |
| 2011-05-20 | Injury | None | None |
| 2011-05-20 | Injury | None | None |
| 2011-05-19 | Injury | None | None |
| 2011-05-19 | Injury | None | None |
| 2011-05-16 | Injury | None | None |
| 2011-05-12 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2011-05-11 | Malfunction | None | Low impedance |
| 2011-05-11 | Malfunction | None | Difficult to Interrogate |
| 2011-05-10 | Malfunction | None | Over-Sensing |
| 2011-05-09 | Malfunction | None | Low impedance |
| 2011-05-06 | Injury | None | Failure to Capture, Under-Sensing |
| 2011-05-06 | Injury | None | None |
| 2011-05-05 | Malfunction | None | Over-Sensing |
| 2011-05-04 | Malfunction | None | High impedance |
| 2011-05-02 | Death | None | None |
| 2011-04-28 | Death | None | None |
| 2011-04-27 | Malfunction | None | None |
| 2011-04-25 | Injury | None | None |
| 2011-04-24 | Injury | None | None |
| 2011-04-24 | Death | None | None |
| 2011-04-22 | Injury | None | None |
| 2011-04-21 | Malfunction | None | None |
| 2011-04-19 | Injury | None | None |
| 2011-04-17 | Injury | None | Inappropriate or Unexpected Reset |
| 2011-04-17 | Malfunction | None | None |
| 2011-04-15 | Injury | None | None |
| 2011-04-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-04-12 | Injury | None | None |
| 2011-04-11 | Injury | None | None |
| 2011-04-08 | Death | None | None |
| 2011-04-05 | Injury | None | None |
| 2011-03-25 | Injury | None | Output Problem |
| 2011-03-21 | Death | None | None |
| 2011-03-10 | Injury | None | None |
| 2011-03-09 | Injury | None | None |
| 2011-03-08 | Injury | None | Premature Elective Replacement Indicator |
| 2011-02-17 | Death | None | None |
| 2011-02-17 | Death | None | None |
| 2011-02-16 | Death | None | None |
| 2011-02-11 | Injury | None | Premature Elective Replacement Indicator |
| 2011-02-10 | Injury | None | None |
| 2011-02-03 | Malfunction | Insufficient Information | Insufficient Information |
| 2011-02-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2011-01-25 | Injury | None | None |
| 2011-01-24 | Death | None | None |
| 2011-01-21 | Injury | None | None |
| 2011-01-21 | Injury | None | None |
| 2011-01-21 | Injury | None | None |
| 2011-01-13 | Injury | None | Premature Discharge of Battery, Telemetry Discrepancy, Output Problem |
| 2011-01-11 | Injury | None | Failure to Interrogate |
| 2011-01-10 | Injury | None | Premature Discharge of Battery |
| 2011-01-07 | Injury | None | None |
| 2011-01-06 | Injury | None | None |
| 2011-01-05 | Death | None | None |
| 2011-01-04 | Injury | None | None |
| 2010-12-30 | Injury | None | None |
| 2010-12-23 | Injury | None | None |
| 2010-12-21 | Death | None | None |
| 2010-12-21 | Injury | None | None |
| 2010-12-17 | Death | None | None |
| 2010-12-08 | Injury | None | None |
| 2010-12-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2010-12-03 | Death | None | None |
| 2010-12-02 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2010-12-01 | Death | None | None |
| 2010-11-29 | Injury | None | None |
| 2010-11-17 | Injury | None | None |
| 2010-11-17 | Injury | None | None |
| 2010-11-12 | Injury | None | None |
| 2010-11-10 | Unknown | None | None |
| 2010-11-10 | Unknown | None | None |
| 2010-11-03 | Malfunction | None | Impedance Problem |
| 2010-10-27 | Injury | None | None |
| 2010-10-26 | Injury | None | None |
| 2010-10-15 | Injury | None | None |
| 2010-10-14 | Injury | None | None |
| 2010-10-06 | Injury | None | None |
| 2010-10-06 | Injury | None | None |
| 2010-09-29 | Malfunction | None | None |
| 2010-09-27 | Injury | None | None |
| 2010-09-16 | Injury | None | None |
| 2010-09-03 | Injury | None | None |
| 2010-09-01 | Injury | None | None |
| 2010-08-30 | Injury | None | None |
| 2010-08-30 | Malfunction | None | Output Problem |
| 2010-08-23 | Injury | None | None |
| 2010-08-19 | Injury | None | None |
| 2010-08-19 | Malfunction | None | None |
| 2010-08-15 | Death | None | None |
| 2010-08-04 | Injury | None | None |
| 2010-07-30 | Death | None | None |
| 2010-07-28 | Malfunction | None | None |
| 2010-07-24 | Malfunction | None | None |
| 2010-07-14 | Injury | None | None |
| 2010-07-13 | Death | None | None |
| 2010-07-13 | Injury | None | None |
| 2010-06-29 | Injury | None | None |
| 2010-06-29 | Injury | None | None |
| 2010-06-23 | Injury | None | None |
| 2010-06-15 | Malfunction | None | None |
| 2010-06-07 | Injury | None | None |
| 2010-05-18 | Injury | None | None |
| 2010-05-11 | Malfunction | None | None |
| 2010-05-07 | Injury | None | None |
| 2010-04-25 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2010-04-20 | Injury | None | None |
| 2010-04-15 | Injury | None | None |
| 2010-04-15 | Injury | None | None |
| 2010-04-12 | Malfunction | None | None |
| 2010-04-08 | Injury | None | None |
| 2010-03-25 | Injury | None | None |
| 2010-03-25 | Malfunction | None | None |
| 2010-03-22 | Injury | None | None |
| 2010-03-22 | Death | None | None |
| 2010-03-10 | Injury | None | None |
| 2010-03-10 | Injury | None | None |
| 2010-03-10 | Injury | None | None |
| 2010-03-04 | Death | None | None |
| 2010-02-18 | Injury | None | None |
| 2010-02-16 | Malfunction | None | None |
| 2010-02-10 | Injury | None | None |
| 2010-01-16 | Malfunction | None | None |
| 2009-12-23 | Injury | None | None |
| 2009-11-12 | Injury | None | None |
| 2009-11-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2009-11-02 | Injury | None | None |
| 2009-10-22 | Malfunction | None | None |
| 2009-10-20 | Injury | None | None |
| 2009-10-08 | Malfunction | None | Delayed Charge Time |
| 2009-10-08 | Malfunction | None | None |
| 2009-07-27 | Injury | None | None |
| 2009-07-08 | Injury | None | None |
| 2009-06-04 | Death | None | None |
| 2009-06-01 | Injury | None | Under-Sensing |
| 2009-03-04 | Death | None | None |