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:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Tactile Prompts/Feedback | 1 | Device |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Premature Discharge of Battery | 2 | Device |
| 2023 | Over-Sensing | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2023 | Inappropriate or Unexpected Reset | 3 | Device |
| 2023 | Defective Device | 2 | Device |
| 2022 | Premature Discharge of Battery | 6 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Over-Sensing | 4 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | Failure to Sense | 1 | Device |
| 2022 | Defective Device | 1 | Device |
| 2020 | Battery Problem | 1 | Device |
| 2019 | Arrhythmia | 1 | Patient |
| 2019 | Under-Sensing | 3 | Device |
| 2019 | Signal Artifact/Noise | 1 | Device |
| 2019 | Premature Discharge of Battery | 6 | Device |
| 2019 | Over-Sensing | 3 | Device |
| 2019 | Migration | 1 | Device |
| 2019 | Low Sensing Threshold | 1 | Device |
| 2019 | Incorrect Interpretation of Signal | 1 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2019 | Inappropriate or Unexpected Reset | 10 | Device |
| 2019 | Failure to Interrogate | 6 | Device |
| 2019 | Failure to Deliver Shock/Stimulation | 2 | Device |
| 2019 | Failure to Convert Rhythm | 1 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Energy Output Problem | 2 | Device |
| 2019 | Defective Alarm | 1 | Device |
| 2019 | Data Problem | 1 | Device |
| 2019 | Communication or Transmission Problem | 3 | Device |
| 2019 | Charging Problem | 1 | Device |
| 2019 | Battery Problem | 31 | Device |
| 2019 | Application Program Version or Upgrade Problem | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2018 | Under-Sensing | 3 | Device |
| 2018 | Telemetry Discrepancy | 2 | Device |
| 2018 | Signal Artifact/Noise | 3 | Device |
| 2018 | Programming Issue | 1 | Device |
| 2018 | Premature Discharge of Battery | 15 | Device |
| 2018 | Over-Sensing | 8 | Device |
| 2018 | Output Problem | 2 | Device |
| 2018 | Operating System Version or Upgrade Problem | 1 | Device |
| 2018 | Incorrect Interpretation of Signal | 3 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2018 | Inappropriate or Unexpected Reset | 7 | Device |
| 2018 | Failure to Interrogate | 7 | Device |
| 2018 | Failure to Capture | 1 | Device |
| 2018 | Defibrillation/Stimulation Problem | 2 | Device |
| 2018 | Data Problem | 2 | Device |
| 2018 | Communication or Transmission Problem | 3 | Device |
| 2018 | Battery Problem | 48 | Device |
| 2018 | Appropriate Term/Code Not Available | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2017 | Insufficient Information | 1 | Patient |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Under-Sensing | 1 | Device |
| 2017 | Telemetry Discrepancy | 1 | Device |
| 2017 | Premature End-of-Life Indicator | 2 | Device |
| 2017 | Premature Elective Replacement Indicator | 4 | Device |
| 2017 | Premature Discharge of Battery | 28 | Device |
| 2017 | Pacing Intermittently | 1 | Device |
| 2017 | Pacing Inadequately | 1 | Device |
| 2017 | Pacing Asynchronously | 1 | Device |
| 2017 | Pacemaker Found in Back-Up Mode | 2 | Device |
| 2017 | Over-Sensing | 15 | Device |
| 2017 | Output Problem | 1 | Device |
| 2017 | Material Distortion | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 9 | Device |
| 2017 | Inappropriate or Unexpected Reset | 6 | Device |
| 2017 | High impedance | 2 | Device |
| 2017 | Failure to Interrogate | 11 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Deformation Due to Compressive Stress | 1 | Device |
| 2017 | Defibrillation/Stimulation Problem | 1 | Device |
| 2017 | Data Problem | 1 | Device |
| 2017 | Battery Problem | 47 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 100 | Device |
| 2016 | Premature Elective Replacement Indicator | 1 | Device |
| 2016 | Premature Discharge of Battery | 13 | Device |
| 2016 | Pacing Problem | 1 | Device |
| 2016 | Over-Sensing | 11 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
| 2016 | Inappropriate or Unexpected Reset | 3 | Device |
| 2016 | Failure to Interrogate | 5 | Device |
| 2016 | Device Operates Differently Than Expected | 2 | Device |
| 2016 | Defibrillation/Stimulation Problem | 2 | Device |
| 2016 | Battery Problem | 1 | Device |
| 2016 | Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 126 | Device |
| 2015 | Premature Elective Replacement Indicator | 1 | Device |
| 2015 | Premature Discharge of Battery | 1 | Device |
| 2015 | Over-Sensing | 1 | Device |
| 2015 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2014 | Ventricular Fibrillation | 1 | Patient |
| 2014 | Under-Sensing | 1 | Device |
| 2014 | Signal Artifact/Noise | 1 | Device |
| 2014 | Over-Sensing | 27 | Device |
| 2014 | Output Problem | 2 | Device |
| 2014 | Migration or Expulsion of Device | 2 | Device |
| 2014 | Loosening of Implant Not Related to Bone-Ingrowth | 1 | Device |
| 2014 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2014 | Inappropriate or Unexpected Reset | 5 | Device |
| 2014 | High impedance | 2 | Device |
| 2014 | Failure to Interrogate | 2 | Device |
| 2014 | Electromagnetic Interference | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 7 | Device |
| 2014 | Delayed Charge Time | 1 | Device |
| 2014 | Defibrillation/Stimulation Problem | 2 | Device |
| 2014 | Decreased Sensitivity | 1 | Device |
| 2014 | Connection Problem | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2013 | Over-Sensing | 10 | Device |
| 2013 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2013 | High impedance | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 4 | Device |
| 2013 | Decreased Sensitivity | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2012 | Under-Sensing | 1 | Device |
| 2012 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2012 | Over-Sensing | 8 | Device |
| 2012 | Failure to Capture | 1 | Device |
| 2012 | Device Operates Differently Than Expected | 1 | Device |