IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
This device is manufactured by ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL - NEUROMODULATION (PUERTO RICO ).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Use of Device Problem | 1 | Device |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Over-Sensing | 5 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2024 | Inappropriate or Unexpected Reset | 1 | Device |
| 2024 | Failure to Interrogate | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Infection | 2 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Under-Sensing | 1 | Device |
| 2023 | Over-Sensing | 2 | Device |
| 2023 | Incorrect Interpretation of Signal | 2 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2023 | Inappropriate or Unexpected Reset | 1 | Device |
| 2023 | Defective Device | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Under-Sensing | 3 | Device |
| 2022 | Tactile Prompts/Feedback | 1 | Device |
| 2022 | Pacing Problem | 2 | Device |
| 2022 | Over-Sensing | 8 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Incorrect Measurement | 1 | Device |
| 2022 | Incorrect Interpretation of Signal | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2022 | Inappropriate or Unexpected Reset | 1 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Wireless Communication Problem | 1 | Device |
| 2020 | Failure to Interrogate | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Under-Sensing | 2 | Device |
| 2019 | Telemetry Discrepancy | 1 | Device |
| 2019 | Signal Artifact/Noise | 5 | Device |
| 2019 | Pacing Asynchronously | 1 | Device |
| 2019 | Over-Sensing | 44 | Device |
| 2019 | No Pacing | 2 | Device |
| 2019 | Misconnection | 1 | Device |
| 2019 | Low impedance | 1 | Device |
| 2019 | Incorrect Interpretation of Signal | 6 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2019 | Inappropriate or Unexpected Reset | 20 | Device |
| 2019 | Failure to Interrogate | 1 | Device |
| 2019 | Failure to Deliver Shock/Stimulation | 2 | Device |
| 2019 | Failure to Convert Rhythm | 1 | Device |
| 2019 | Failure to Charge | 5 | Device |
| 2019 | Failure to Capture | 3 | Device |
| 2019 | Delayed Charge Time | 2 | Device |
| 2019 | Defective Alarm | 1 | Device |
| 2019 | Data Problem | 6 | Device |
| 2019 | Connection Problem | 1 | Device |
| 2019 | Communication or Transmission Problem | 2 | Device |
| 2019 | Appropriate Term/Code Not Available | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2018 | Wireless Communication Problem | 1 | Device |
| 2018 | Under-Sensing | 4 | Device |
| 2018 | Telemetry Discrepancy | 2 | Device |
| 2018 | Signal Artifact/Noise | 7 | Device |
| 2018 | Reset Problem | 1 | Device |
| 2018 | Programming Issue | 2 | Device |
| 2018 | Premature Discharge of Battery | 3 | Device |
| 2018 | Pacing Problem | 1 | Device |
| 2018 | Over-Sensing | 60 | Device |
| 2018 | Output Problem | 2 | Device |
| 2018 | No Pacing | 1 | Device |
| 2018 | Low impedance | 1 | Device |
| 2018 | Incorrect Interpretation of Signal | 1 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2018 | Inappropriate or Unexpected Reset | 18 | Device |
| 2018 | High impedance | 1 | Device |
| 2018 | Failure to Interrogate | 2 | Device |
| 2018 | Failure to Deliver Shock/Stimulation | 2 | Device |
| 2018 | Failure to Charge | 3 | Device |
| 2018 | Failure to Capture | 1 | Device |
| 2018 | Electromagnetic Interference | 1 | Device |
| 2018 | Difficult to Interrogate | 1 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Delayed Charge Time | 16 | Device |
| 2018 | Defibrillation/Stimulation Problem | 2 | Device |
| 2018 | Data Problem | 4 | Device |
| 2018 | Communication or Transmission Problem | 4 | Device |
| 2018 | Battery Problem | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 4 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 20 | Device |
| 2017 | Wireless Communication Problem | 1 | Device |
| 2017 | Under-Sensing | 6 | Device |
| 2017 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2017 | Telemetry Discrepancy | 1 | Device |
| 2017 | Signal Artifact/Noise | 3 | Device |
| 2017 | Programming Issue | 3 | Device |
| 2017 | Premature Elective Replacement Indicator | 2 | Device |
| 2017 | Premature Discharge of Battery | 4 | Device |
| 2017 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2017 | Over-Sensing | 54 | Device |
| 2017 | Output Problem | 1 | Device |
| 2017 | Nonstandard Device | 1 | Device |
| 2017 | Noise, Audible | 1 | Device |
| 2017 | Missing Test Results | 1 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Low impedance | 1 | Device |
| 2017 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2017 | Incorrect Interpretation of Signal | 2 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 19 | Device |
| 2017 | Inappropriate or Unexpected Reset | 18 | Device |
| 2017 | High impedance | 3 | Device |
| 2017 | Failure to Convert Rhythm | 1 | Device |
| 2017 | Failure to Capture | 2 | Device |
| 2017 | Difficult to Interrogate | 1 | Device |
| 2017 | Device Sensing Problem | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 5 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Device Alarm System | 1 | Device |
| 2017 | Delayed Charge Time | 16 | Device |
| 2017 | Delamination | 1 | Device |
| 2017 | Connection Problem | 2 | Device |
| 2017 | Communication or Transmission Problem | 3 | Device |
| 2017 | Charging Problem | 2 | Device |
| 2017 | Changes In Ambient Temperature In Device Environment | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2016 | Wireless Communication Problem | 1 | Device |
| 2016 | Under-Sensing | 3 | Device |
| 2016 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2016 | Programming Issue | 1 | Device |
| 2016 | Premature Elective Replacement Indicator | 1 | Device |
| 2016 | Premature Discharge of Battery | 2 | Device |
| 2016 | Pacing Problem | 3 | Device |
| 2016 | Pacing Inadequately | 1 | Device |
| 2016 | Over-Sensing | 47 | Device |
| 2016 | Output Problem | 2 | Device |
| 2016 | Nonstandard Device | 2 | Device |
| 2016 | Low Battery | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2016 | Inappropriate or Unexpected Reset | 6 | Device |
| 2016 | High impedance | 7 | Device |
| 2016 | Flaked | 1 | Device |
| 2016 | Failure to Convert Rhythm | 1 | Device |
| 2016 | Failure to Capture | 1 | Device |
| 2016 | Difficult to Interrogate | 1 | Device |
| 2016 | Device Sensing Problem | 2 | Device |
| 2016 | Device Operates Differently Than Expected | 11 | Device |
| 2016 | Delayed Charge Time | 10 | Device |
| 2016 | Defibrillation/Stimulation Problem | 1 | Device |
| 2016 | Decreased Sensitivity | 1 | Device |
| 2016 | Connection Problem | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Over-Sensing | 3 | Device |
| 2015 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2015 | Inappropriate or Unexpected Reset | 3 | Device |
| 2015 | Electromagnetic Interference | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 1 | Device |
| 2015 | Delayed Charge Time | 1 | Device |