IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
This device is manufactured by ABBOTT, ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL - NEUROMODULATION (PUERTO RICO ), ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION.
The following problems were reported about this device:
Date | Event Type | Patient Problem | Device Problem |
---|---|---|---|
2019-09-19 | Injury | None | High impedance |
2019-09-16 | Injury | None | Premature Discharge of Battery, Battery Problem |
2019-09-09 | Malfunction | None | Over-Sensing |
2019-08-15 | Injury | None | Premature Discharge of Battery |
2019-08-14 | Malfunction | None | Over-Sensing |
2019-07-29 | Injury | None | Premature Discharge of Battery, Failure to Interrogate |
2019-07-18 | Malfunction | None | Over-Sensing |
2019-06-27 | Malfunction | None | Over-Sensing |
2019-06-21 | Injury | None | Battery Problem |
2019-06-14 | Death | None | Adverse Event Without Identified Device or Use Problem |
2019-06-11 | Injury | None | Battery Problem |
2019-06-06 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
2019-05-21 | Malfunction | None | Over-Sensing |
2019-05-08 | Malfunction | None | Misconnection |
2019-05-07 | Malfunction | None | Over-Sensing |
2019-04-29 | Injury | None | Battery Problem |
2019-04-23 | Injury | None | Battery Problem |
2019-04-17 | Injury | None | Battery Problem |
2019-04-15 | Malfunction | None | Communication or Transmission Problem, Inappropriate or Unexpected Reset |
2019-04-03 | Malfunction | None | Over-Sensing |
2019-02-04 | Malfunction | None | Battery Problem |
2019-01-23 | Injury | None | Premature Discharge of Battery, Battery Problem |
2019-01-15 | Injury | None | Battery Problem |
2019-01-06 | Injury | None | Battery Problem |
2019-01-03 | Injury | None | Battery Problem |
2018-12-12 | Malfunction | None | Over-Sensing |
2018-12-12 | Injury | None | Battery Problem |
2018-12-08 | Injury | None | Battery Problem |
2018-11-21 | Injury | None | Signal Artifact/Noise, Inappropriate/Inadequate Shock/Stimulation |
2018-11-19 | Malfunction | None | Over-Sensing |
2018-11-15 | Malfunction | None | Over-Sensing |
2018-11-08 | Malfunction | None | Over-Sensing |
2018-11-05 | Injury | None | Battery Problem |
2018-10-31 | Malfunction | None | Over-Sensing |
2018-10-29 | Malfunction | None | Inappropriate or Unexpected Reset |
2018-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-10-19 | Injury | None | Battery Problem |
2018-10-18 | Malfunction | None | Under-Sensing |
2018-10-16 | Injury | None | Battery Problem |
2018-10-02 | Injury | None | Battery Problem |
2018-09-29 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
2018-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-09-25 | Malfunction | None | Battery Problem |
2018-09-24 | Malfunction | None | Battery Problem |
2018-09-23 | Malfunction | None | Over-Sensing |
2018-09-19 | Malfunction | None | Signal Artifact/Noise, Over-Sensing |
2018-09-18 | Injury | None | Battery Problem |
2018-09-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-09-17 | Injury | None | Inappropriate or Unexpected Reset |
2018-09-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-09-07 | Malfunction | None | Over-Sensing |
2018-08-23 | Injury | None | High impedance |
2018-08-22 | Malfunction | None | Over-Sensing |
2018-08-04 | Injury | None | Battery Problem |
2018-07-24 | Injury | None | Battery Problem |
2018-07-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-07-19 | Injury | None | Premature Discharge of Battery |
2018-07-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-07-13 | Malfunction | None | Over-Sensing |
2018-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-07-07 | Injury | None | Battery Problem |
2018-07-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-07-03 | Injury | None | Premature Discharge of Battery, Failure to Interrogate |
2018-06-30 | Injury | None | Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation |
2018-06-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-06-28 | Injury | None | Battery Problem |
2018-06-21 | Injury | None | Battery Problem |
2018-06-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-06-07 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Programming Issue |
2018-06-05 | Injury | None | Battery Problem |
2018-05-22 | Injury | None | Battery Problem |
2018-05-22 | Injury | None | Premature Discharge of Battery |
2018-05-21 | Malfunction | None | Over-Sensing |
2018-05-16 | Malfunction | None | Failure to Interrogate |
2018-05-02 | Injury | None | Inappropriate or Unexpected Reset |
2018-04-23 | Injury | None | Premature Discharge of Battery, Failure to Interrogate |
2018-04-16 | Injury | None | Battery Problem |
2018-04-11 | Malfunction | None | Over-Sensing |
2018-04-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-03-29 | Malfunction | None | Failure to Deliver Shock/Stimulation, Inappropriate or Unexpected Reset |
2018-03-28 | Injury | None | Battery Problem |
2018-03-28 | Injury | None | Failure to Interrogate |
2018-03-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-03-13 | Injury | None | Battery Problem |
2018-03-02 | Malfunction | None | Over-Sensing |
2018-02-20 | Malfunction | None | Over-Sensing |
2018-02-07 | Malfunction | None | Over-Sensing |
2018-02-01 | Malfunction | None | Communication or Transmission Problem, Inappropriate or Unexpected Reset |
2018-01-31 | Malfunction | None | Over-Sensing |
2018-01-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-01-29 | Injury | None | Battery Problem |
2018-01-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2018-01-18 | Malfunction | None | Inappropriate or Unexpected Reset |
2018-01-16 | Malfunction | None | Over-Sensing |
2018-01-09 | Injury | None | Battery Problem |
2018-01-08 | Malfunction | None | Under-Sensing |
2018-01-05 | Injury | None | Battery Problem |
2018-01-02 | Malfunction | None | Over-Sensing |
2018-01-01 | Malfunction | None | Over-Sensing |
2017-12-26 | Malfunction | None | Over-Sensing |
2017-12-26 | Malfunction | None | Inappropriate or Unexpected Reset |
2017-12-21 | Malfunction | None | Signal Artifact/Noise |
2017-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-12-19 | Malfunction | None | Over-Sensing |
2017-12-13 | Malfunction | None | Communication or Transmission Problem |
2017-12-08 | Malfunction | None | Over-Sensing |
2017-12-08 | Malfunction | None | Over-Sensing |
2017-12-05 | Injury | None | Battery Problem |
2017-12-05 | Injury | None | Battery Problem |
2017-12-04 | Injury | None | Battery Problem |
2017-11-24 | Malfunction | None | Communication or Transmission Problem, Inappropriate or Unexpected Reset |
2017-11-19 | Injury | None | Battery Problem |
2017-11-18 | Malfunction | None | Over-Sensing |
2017-11-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-11-16 | Malfunction | None | Over-Sensing |
2017-11-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-11-09 | Malfunction | None | Incorrect Measurement |
2017-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-11-07 | Malfunction | None | Over-Sensing |
2017-11-06 | Malfunction | None | Over-Sensing |
2017-11-04 | Malfunction | None | Signal Artifact/Noise, Over-Sensing |
2017-11-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-10-27 | Malfunction | None | Device Alarm System |
2017-10-27 | Malfunction | None | Over-Sensing |
2017-10-25 | Malfunction | None | Over-Sensing |
2017-10-24 | Malfunction | None | Over-Sensing |
2017-10-19 | Malfunction | None | Inappropriate or Unexpected Reset |
2017-10-18 | Malfunction | None | Over-Sensing |
2017-10-16 | Injury | None | Premature Discharge of Battery, Failure to Interrogate |
2017-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-10-08 | Malfunction | None | Over-Sensing |
2017-10-06 | Malfunction | None | Over-Sensing |
2017-10-03 | Malfunction | None | Over-Sensing |
2017-10-03 | Malfunction | None | Over-Sensing |
2017-09-28 | Malfunction | None | Over-Sensing |
2017-09-27 | Malfunction | None | Over-Sensing |
2017-09-26 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
2017-09-22 | Malfunction | None | Over-Sensing |
2017-09-22 | Malfunction | None | Over-Sensing |
2017-09-21 | Injury | None | Premature Discharge of Battery |
2017-09-20 | Malfunction | None | Over-Sensing |
2017-09-18 | Malfunction | None | Incorrect Interpretation of Signal |
2017-09-18 | Injury | None | Premature Discharge of Battery |
2017-09-12 | Malfunction | None | Over-Sensing |
2017-09-12 | Malfunction | None | Over-Sensing |
2017-09-09 | Malfunction | None | Over-Sensing |
2017-09-08 | Injury | None | Premature Discharge of Battery |
2017-09-05 | Malfunction | None | Defibrillation/Stimulation Problem |
2017-08-25 | Malfunction | None | Over-Sensing |
2017-08-24 | Injury | None | Device Alarm System, Premature Discharge of Battery |
2017-08-22 | Injury | None | Premature Discharge of Battery |
2017-08-16 | Malfunction | None | Over-Sensing |
2017-08-14 | Malfunction | None | Premature Discharge of Battery |
2017-08-13 | Malfunction | None | Communication or Transmission Problem, Inappropriate or Unexpected Reset |
2017-08-11 | Malfunction | None | Over-Sensing |
2017-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-07-12 | Injury | None | Premature Discharge of Battery |
2017-07-07 | Malfunction | None | Over-Sensing |
2017-07-06 | Injury | None | Signal Artifact/Noise, Over-Sensing |
2017-07-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-07-05 | Malfunction | None | Over-Sensing |
2017-07-05 | Malfunction | None | Over-Sensing, Device Sensing Problem |
2017-06-29 | Malfunction | None | Over-Sensing |
2017-06-26 | Malfunction | None | Over-Sensing |
2017-06-16 | Malfunction | None | Over-Sensing |
2017-06-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-06-05 | Injury | None | Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem |
2017-06-01 | Injury | None | Premature Discharge of Battery, Inappropriate or Unexpected Reset |
2017-05-29 | Malfunction | None | Over-Sensing |
2017-05-23 | Malfunction | None | Over-Sensing |
2017-05-16 | Malfunction | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
2017-05-15 | Malfunction | None | Over-Sensing |
2017-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-05-14 | Malfunction | None | Over-Sensing |
2017-05-10 | Malfunction | None | Over-Sensing |
2017-05-08 | Malfunction | None | Over-Sensing |
2017-05-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-05-01 | Malfunction | None | Over-Sensing |
2017-04-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-26 | Malfunction | None | Over-Sensing |
2017-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-24 | Malfunction | None | Inappropriate or Unexpected Reset |
2017-04-21 | Malfunction | None | Over-Sensing |
2017-04-20 | Malfunction | None | Over-Sensing |
2017-04-20 | Malfunction | None | Over-Sensing |
2017-04-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-07 | Injury | None | Premature Discharge of Battery |
2017-04-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-04-02 | Malfunction | None | Over-Sensing |
2017-03-31 | Malfunction | None | Over-Sensing |
2017-03-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-29 | Injury | None | Premature Discharge of Battery |
2017-03-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-27 | Death | None | Adverse Event Without Identified Device or Use Problem |
2017-03-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-24 | Malfunction | None | Over-Sensing |
2017-03-23 | Malfunction | None | Over-Sensing |
2017-03-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-20 | Malfunction | None | Over-Sensing |
2017-03-20 | Injury | None | Premature Discharge of Battery |
2017-03-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-15 | Malfunction | None | Over-Sensing |
2017-03-13 | Malfunction | None | Inappropriate or Unexpected Reset |
2017-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-08 | Injury | None | Premature Discharge of Battery, Low impedance, Delayed Charge Time |
2017-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-03-03 | 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 | Over-Sensing |
2017-02-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-02-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-02-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-02-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-02-21 | Malfunction | None | Over-Sensing |
2017-02-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-02-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-02-16 | Malfunction | None | Over-Sensing |
2017-02-16 | Malfunction | None | Over-Sensing |
2017-02-08 | Injury | None | Premature Discharge of Battery |
2017-02-07 | Malfunction | None | Over-Sensing |
2017-02-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-02-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-02-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-25 | Malfunction | None | High impedance |
2017-01-21 | Malfunction | None | Over-Sensing |
2017-01-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-11 | Malfunction | None | Over-Sensing |
2017-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-06 | Malfunction | None | Over-Sensing |
2017-01-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-04 | Malfunction | None | Break |
2017-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-02 | Injury | None | Over-Sensing, Failure to Analyze Signal |
2017-01-01 | Death | None | Adverse Event Without Identified Device or Use Problem |
2016-12-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-22 | Malfunction | None | Over-Sensing |
2016-12-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-21 | Malfunction | None | Pacemaker Found in Back-Up Mode |
2016-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-19 | Malfunction | None | Over-Sensing |
2016-12-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-15 | Injury | None | Device Alarm System |
2016-12-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-07 | Injury | None | Device Alarm System |
2016-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-06 | Injury | None | Vibration |
2016-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-01 | Malfunction | None | Over-Sensing |
2016-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-24 | Death | None | Defibrillation/Stimulation Problem |
2016-11-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-22 | Malfunction | None | Over-Sensing |
2016-11-22 | Malfunction | None | Over-Sensing |
2016-11-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-17 | Malfunction | None | Delayed Charge Time |
2016-11-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-17 | Injury | None | Device Alarm System |
2016-11-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-16 | Malfunction | None | Over-Sensing |
2016-11-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-15 | Malfunction | None | Over-Sensing |
2016-11-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-14 | Malfunction | None | Over-Sensing |
2016-11-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-05 | Death | None | Adverse Event Without Identified Device or Use Problem |
2016-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-04 | Malfunction | None | Over-Sensing |
2016-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-02 | Injury | None | Device Operates Differently Than Expected |
2016-11-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-11-01 | Malfunction | None | Over-Sensing |
2016-10-31 | Malfunction | None | Over-Sensing |
2016-10-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-10-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-10-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-10-20 | Malfunction | None | Over-Sensing |
2016-10-20 | Malfunction | None | Over-Sensing |
2016-10-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-10-13 | Malfunction | None | Over-Sensing |
2016-10-12 | Injury | None | Nonstandard Device, Adverse Event Without Identified Device or Use Problem |
2016-09-29 | Malfunction | None | Over-Sensing |
2016-09-29 | Malfunction | None | Over-Sensing |
2016-09-28 | Malfunction | None | Over-Sensing |
2016-09-16 | Malfunction | None | Over-Sensing, Device Operates Differently Than Expected |
2016-09-15 | Injury | None | Defibrillation/Stimulation Problem, Inappropriate or Unexpected Reset, Output Problem |
2016-09-10 | Malfunction | None | Over-Sensing, Device Operates Differently Than Expected |
2016-09-05 | Malfunction | None | Inappropriate or Unexpected Reset |
2016-08-25 | Malfunction | None | Over-Sensing |
2016-08-19 | Injury | None | Delayed Charge Time, Noise, Audible |
2016-08-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2016-08-09 | Malfunction | None | Over-Sensing |
2016-08-09 | Malfunction | None | Over-Sensing |
2016-07-28 | Injury | None | Premature Discharge of Battery, Difficult to Interrogate, Pacing Problem, Material Deformation |
2016-07-28 | Malfunction | None | Over-Sensing, Device Operates Differently Than Expected |
2016-07-19 | Malfunction | None | Over-Sensing |
2016-07-13 | Malfunction | None | Over-Sensing |
2016-07-11 | Malfunction | None | Over-Sensing |
2016-06-21 | Malfunction | None | Over-Sensing |
2016-06-02 | Injury | None | Over-Sensing, Low impedance, Connection Problem, Inappropriate or Unexpected Reset |
2016-04-22 | Malfunction | None | Over-Sensing |
2015-12-12 | Malfunction | None | Over-Sensing |
2015-04-22 | Malfunction | None | Over-Sensing |
2015-04-16 | Malfunction | None | Over-Sensing |
2015-04-15 | Malfunction | None | Over-Sensing |
2015-04-09 | Malfunction | None | Failure to Interrogate |
2015-04-08 | Malfunction | None | Device Sensing Problem |
2015-04-07 | Malfunction | None | Over-Sensing |
2015-04-06 | Malfunction | None | Over-Sensing |
2015-04-01 | Injury | None | Failure to Interrogate |
2015-03-31 | Malfunction | None | Device Operates Differently Than Expected |
2015-03-16 | Malfunction | None | Over-Sensing |
2015-03-05 | Malfunction | None | Over-Sensing |
2015-03-05 | Malfunction | None | Over-Sensing |
2015-03-01 | Malfunction | None | Over-Sensing |
2015-02-11 | Malfunction | None | Over-Sensing |
2015-02-10 | Malfunction | None | Over-Sensing |
2015-02-05 | Malfunction | None | Over-Sensing |
2014-12-11 | Malfunction | None | Over-Sensing |
2014-07-24 | Malfunction | None | Over-Sensing, Device Operates Differently Than Expected |
2014-07-03 | Malfunction | None | Over-Sensing |
2014-06-24 | Malfunction | None | Over-Sensing |
2014-06-18 | Malfunction | None | Over-Sensing |
2014-06-13 | Malfunction | None | Over-Sensing |
2014-06-11 | Malfunction | None | Connection Problem |
2014-06-04 | Malfunction | None | Over-Sensing |
2014-06-04 | Malfunction | None | Over-Sensing |
2014-06-03 | Malfunction | None | Over-Sensing |
2014-05-28 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
2014-05-24 | Malfunction | None | Over-Sensing |
2014-05-24 | Malfunction | None | Over-Sensing |
2014-05-23 | Malfunction | None | Over-Sensing |
2014-05-23 | Malfunction | None | Over-Sensing |
2014-05-23 | Injury | None | High impedance, Loose or Intermittent Connection, Over-Sensing |
2014-05-22 | Malfunction | None | Over-Sensing |
2014-05-21 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
2014-05-21 | Malfunction | None | Over-Sensing |
2014-05-20 | Malfunction | None | Over-Sensing |
2014-05-19 | Injury | None | Failure to Interrogate, Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset |
2014-05-18 | Malfunction | None | Over-Sensing |
2014-05-17 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation |
2014-05-15 | Malfunction | None | Connection Problem |
2014-05-13 | Malfunction | None | Over-Sensing |
2014-05-12 | Malfunction | None | Over-Sensing |
2014-05-12 | Malfunction | None | Device Operates Differently Than Expected |
2014-05-09 | Malfunction | None | Over-Sensing |
2014-05-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2014-05-02 | Malfunction | None | Over-Sensing |
2014-04-30 | Injury | None | Migration or Expulsion of Device |
2014-04-30 | Malfunction | None | Over-Sensing |
2014-04-28 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
2014-04-26 | Malfunction | None | Over-Sensing |
2014-04-25 | Malfunction | None | Over-Sensing, Device Operates Differently Than Expected |
2014-04-23 | Malfunction | None | Over-Sensing |
2014-04-19 | Malfunction | None | Over-Sensing, Pacing Problem |
2014-04-15 | Malfunction | None | Over-Sensing |
2014-04-15 | Malfunction | None | Over-Sensing |
2014-04-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2014-04-12 | Death | None | Adverse Event Without Identified Device or Use Problem |
2014-04-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2014-04-08 | Malfunction | None | Over-Sensing |
2014-04-04 | Malfunction | None | Over-Sensing, Device Operates Differently Than Expected |
2014-03-31 | Malfunction | None | Over-Sensing |
2014-03-28 | Malfunction | None | Over-Sensing |
2014-03-26 | Malfunction | None | Over-Sensing |
2014-03-25 | Malfunction | None | Over-Sensing |
2014-03-25 | Malfunction | None | Over-Sensing |
2014-03-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2014-03-19 | Malfunction | None | Device Operates Differently Than Expected |
2014-03-17 | Malfunction | None | Over-Sensing |
2014-03-17 | Malfunction | None | Over-Sensing |
2014-03-14 | Malfunction | None | Over-Sensing |
2014-03-13 | Injury | None | Failure to Interrogate, Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset |
2014-03-13 | Malfunction | None | Under-Sensing, Device Operates Differently Than Expected |
2014-03-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2014-03-10 | Malfunction | None | Over-Sensing |
2014-03-10 | Malfunction | None | High impedance, Connection Problem |
2014-03-01 | Malfunction | None | Under-Sensing |
2014-02-28 | Malfunction | None | Over-Sensing |
2014-02-27 | Malfunction | None | Over-Sensing |
2014-02-24 | Malfunction | None | Over-Sensing |
2014-02-23 | Malfunction | None | Over-Sensing, Device Operates Differently Than Expected |
2014-02-17 | Malfunction | None | Device Operates Differently Than Expected |
2014-02-13 | Malfunction | None | Electromagnetic Interference, Device Operates Differently Than Expected |
2014-02-12 | Malfunction | None | Over-Sensing |
2014-02-11 | Malfunction | None | Over-Sensing |
2014-02-06 | Malfunction | None | Device Operates Differently Than Expected |
2014-02-05 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
2014-02-05 | Malfunction | None | Over-Sensing |
2014-01-29 | Malfunction | None | Over-Sensing |
2014-01-27 | Malfunction | None | Over-Sensing |
2014-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2014-01-24 | Malfunction | None | Over-Sensing |
2014-01-23 | Malfunction | None | Over-Sensing |
2014-01-22 | Malfunction | None | Over-Sensing |
2014-01-20 | Malfunction | None | Over-Sensing |
2014-01-20 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset |
2014-01-17 | Malfunction | None | Over-Sensing |
2014-01-15 | Malfunction | None | Over-Sensing |
2014-01-14 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Output Problem |
2014-01-13 | Malfunction | None | Over-Sensing, Device Operates Differently Than Expected |
2014-01-07 | Malfunction | None | Over-Sensing |
2014-01-05 | Malfunction | None | Over-Sensing |
2014-01-05 | Malfunction | None | Over-Sensing |
2014-01-03 | Malfunction | None | Over-Sensing |
2013-12-30 | Malfunction | None | Over-Sensing |
2013-12-29 | Malfunction | None | Over-Sensing |
2013-12-27 | Malfunction | None | Over-Sensing |
2013-12-24 | Malfunction | None | Over-Sensing |
2013-12-24 | Malfunction | None | Over-Sensing |
2013-12-18 | Injury | None | Failure to Convert Rhythm, Device Operates Differently Than Expected |
2013-12-17 | Malfunction | None | Premature Discharge of Battery |
2013-12-17 | Malfunction | None | Over-Sensing |
2013-12-16 | Malfunction | None | Over-Sensing |
2013-12-11 | Malfunction | None | None |
2013-12-11 | Malfunction | None | Over-Sensing |
2013-12-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2013-12-09 | Malfunction | None | Over-Sensing |
2013-12-08 | Malfunction | None | Inappropriate or Unexpected Reset |
2013-12-06 | Injury | None | Connection Problem |
2013-12-04 | Malfunction | None | Over-Sensing |
2013-12-03 | Malfunction | None | Over-Sensing |
2013-12-03 | Malfunction | None | Over-Sensing |
2013-12-02 | Malfunction | None | Over-Sensing |
2013-12-02 | Malfunction | None | Failure to Analyze Signal |
2013-12-02 | Malfunction | None | False Alarm, Over-Sensing |
2013-12-01 | Death | None | None |
2013-11-29 | Malfunction | None | None |
2013-11-28 | Malfunction | None | None |
2013-11-25 | Malfunction | None | None |
2013-11-22 | Malfunction | None | None |
2013-11-22 | Malfunction | None | Over-Sensing |
2013-11-22 | Malfunction | None | Failure to Sense, Low impedance |
2013-11-20 | Malfunction | None | None |
2013-11-20 | Malfunction | None | None |
2013-11-18 | Malfunction | None | Over-Sensing |
2013-11-18 | Malfunction | None | Over-Sensing |
2013-11-16 | Malfunction | None | None |
2013-11-13 | Malfunction | None | None |
2013-11-12 | Malfunction | None | Over-Sensing |
2013-11-11 | Malfunction | None | None |
2013-11-06 | Injury | None | None |
2013-11-05 | Malfunction | None | Over-Sensing |
2013-11-05 | Malfunction | None | Over-Sensing |
2013-11-05 | Malfunction | None | None |
2013-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2013-11-04 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
2013-11-04 | Malfunction | None | None |
2013-11-01 | Malfunction | None | Over-Sensing |
2013-10-31 | Malfunction | None | None |
2013-10-26 | Malfunction | None | Device Operates Differently Than Expected |
2013-10-24 | Malfunction | None | None |
2013-10-11 | Malfunction | None | None |
2013-10-09 | Malfunction | None | None |
2013-10-06 | Malfunction | None | Loss of Data |
2013-10-04 | Injury | None | None |
2013-10-03 | Malfunction | None | None |
2013-10-02 | Injury | None | None |
2013-09-30 | Malfunction | None | None |
2013-09-30 | Malfunction | None | None |
2013-09-29 | Malfunction | None | None |
2013-09-27 | Malfunction | None | None |
2013-09-27 | Malfunction | None | None |
2013-09-25 | Malfunction | None | None |
2013-09-20 | Injury | None | None |
2013-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2013-09-19 | Malfunction | None | None |
2013-09-18 | Malfunction | None | None |
2013-09-17 | Malfunction | None | None |
2013-09-13 | Malfunction | None | None |
2013-09-12 | Malfunction | None | None |
2013-09-10 | Malfunction | None | None |
2013-09-09 | Malfunction | None | None |
2013-09-09 | Injury | None | None |
2013-09-07 | Injury | None | None |
2013-09-06 | Injury | None | None |
2013-09-04 | Malfunction | None | None |
2013-09-03 | Malfunction | None | None |
2013-09-03 | Malfunction | None | None |
2013-09-03 | Malfunction | None | None |
2013-08-30 | Malfunction | None | None |
2013-08-29 | Malfunction | None | None |
2013-08-29 | Malfunction | None | None |
2013-08-28 | Malfunction | None | None |
2013-08-28 | Malfunction | None | None |
2013-08-27 | Injury | None | None |
2013-08-15 | Injury | None | None |
2013-08-15 | Malfunction | None | None |
2013-08-12 | Injury | None | None |
2013-08-01 | Malfunction | None | None |
2013-08-01 | Malfunction | None | None |
2013-07-31 | Malfunction | None | None |
2013-07-30 | Injury | None | None |
2013-07-29 | Malfunction | None | None |
2013-07-24 | Malfunction | None | None |
2013-07-23 | Malfunction | None | None |
2013-07-22 | Malfunction | None | None |
2013-07-22 | Malfunction | None | None |
2013-07-19 | Injury | None | None |
2013-07-19 | Malfunction | None | None |
2013-07-18 | Malfunction | None | None |
2013-07-17 | Malfunction | None | None |
2013-07-17 | Injury | None | None |
2013-07-16 | Malfunction | None | None |
2013-07-15 | Malfunction | None | None |
2013-07-10 | Malfunction | None | None |
2013-07-09 | Malfunction | None | None |
2013-07-06 | Malfunction | None | None |
2013-07-03 | Malfunction | None | None |
2013-07-01 | Malfunction | None | None |
2013-06-28 | Malfunction | None | None |
2013-06-25 | Malfunction | None | None |
2013-06-24 | Malfunction | None | None |
2013-06-24 | Malfunction | None | None |
2013-06-20 | Malfunction | None | None |
2013-06-20 | Malfunction | None | None |
2013-06-19 | Malfunction | None | None |
2013-06-19 | Malfunction | None | None |
2013-06-19 | Malfunction | None | None |
2013-06-19 | Injury | None | None |
2013-06-18 | Injury | None | None |
2013-06-17 | Malfunction | None | None |
2013-06-13 | Malfunction | None | None |
2013-06-12 | Malfunction | None | None |
2013-06-10 | Malfunction | None | None |
2013-06-10 | Malfunction | None | None |
2013-06-09 | Malfunction | None | None |
2013-06-06 | Malfunction | None | None |
2013-06-06 | Malfunction | None | None |
2013-06-05 | Malfunction | None | None |
2013-06-04 | Malfunction | None | None |
2013-05-30 | Malfunction | None | None |
2013-05-30 | Malfunction | None | None |
2013-05-29 | Malfunction | None | None |
2013-05-29 | Malfunction | None | None |
2013-05-28 | Injury | None | None |
2013-05-24 | Injury | None | None |
2013-05-23 | Malfunction | None | None |
2013-05-22 | Malfunction | None | None |
2013-05-17 | Injury | None | None |
2013-05-17 | Malfunction | None | None |
2013-05-13 | Malfunction | None | None |
2013-05-13 | Injury | None | None |
2013-05-08 | Malfunction | None | None |
2013-05-08 | Malfunction | None | None |
2013-05-07 | Malfunction | None | None |
2013-05-06 | Injury | None | None |
2013-05-01 | Malfunction | None | None |
2013-04-29 | Malfunction | None | None |
2013-04-29 | Malfunction | None | None |
2013-04-24 | Malfunction | None | None |
2013-04-23 | Malfunction | None | None |
2013-04-16 | Malfunction | None | None |
2013-04-12 | Malfunction | None | None |
2013-04-11 | Malfunction | None | None |
2013-04-11 | Malfunction | None | None |
2013-04-09 | Malfunction | None | None |
2013-04-09 | Malfunction | None | None |
2013-04-05 | Malfunction | None | None |
2013-04-04 | Malfunction | None | None |
2013-04-03 | Death | None | None |
2013-03-26 | Injury | None | None |
2013-03-25 | Malfunction | None | None |
2013-03-14 | Malfunction | None | None |
2013-03-13 | Malfunction | None | None |
2013-03-13 | Malfunction | None | None |
2013-03-12 | Malfunction | None | None |
2013-03-11 | Malfunction | None | None |
2013-03-07 | Malfunction | None | None |
2013-03-07 | Malfunction | None | None |
2013-03-06 | Malfunction | None | None |
2013-03-04 | Injury | None | None |
2013-02-26 | Malfunction | None | None |
2013-02-25 | Malfunction | None | None |
2013-02-25 | Malfunction | None | None |
2013-02-20 | Injury | None | None |
2013-02-19 | Malfunction | None | None |
2013-02-19 | Malfunction | None | None |
2013-02-15 | Malfunction | None | None |
2013-02-14 | Malfunction | None | None |
2013-02-11 | Malfunction | None | None |
2013-02-06 | Injury | None | None |
2013-02-06 | Malfunction | None | None |
2013-02-05 | Malfunction | None | None |
2013-02-04 | Malfunction | None | None |
2013-01-12 | Malfunction | None | None |
2013-01-10 | Malfunction | None | Over-Sensing |
2013-01-07 | Malfunction | None | None |
2013-01-07 | Malfunction | None | None |
2012-12-31 | Malfunction | None | None |
2012-11-08 | Malfunction | None | Over-Sensing |
2012-09-26 | Malfunction | None | Over-Sensing |
2012-08-23 | Malfunction | None | Over-Sensing |
2012-05-30 | Malfunction | None | Premature Discharge of Battery |
2012-04-25 | Malfunction | None | Over-Sensing |