IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
This device is manufactured by ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL - NEUROMODULATION (PUERTO RICO ), ST JUDE MEDICAL / ABBOTT MEDICAL.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 1 | Patient |
| 2024 | Unspecified Infection | 3 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2024 | Discomfort | 2 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Under-Sensing | 4 | Device |
| 2024 | Signal Artifact/Noise | 1 | Device |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Pacing Problem | 2 | Device |
| 2024 | Pacing Asynchronously | 2 | Device |
| 2024 | Over-Sensing | 9 | Device |
| 2024 | Incorrect Interpretation of Signal | 2 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 1 | Device |
| 2024 | Failure to Convert Rhythm | 1 | Device |
| 2024 | Failure to Charge | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2023 | Unspecified Infection | 3 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Arrhythmia | 4 | Patient |
| 2023 | Under-Sensing | 4 | Device |
| 2023 | Pacing Asynchronously | 2 | Device |
| 2023 | Over-Sensing | 8 | Device |
| 2023 | No Apparent Adverse Event | 1 | Device |
| 2023 | Low impedance | 1 | Device |
| 2023 | Interrogation Problem | 1 | Device |
| 2023 | Incorrect Measurement | 2 | Device |
| 2023 | Incorrect Interpretation of Signal | 8 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2023 | Inappropriate or Unexpected Reset | 2 | Device |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Failure to Deliver Shock/Stimulation | 3 | Device |
| 2023 | Failure to Convert Rhythm | 1 | Device |
| 2023 | Failure to Charge | 1 | Device |
| 2023 | Delayed Charge Time | 1 | Device |
| 2023 | Defective Device | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2022 | Arrhythmia | 1 | Patient |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Pacing Problem | 3 | Device |
| 2022 | Over-Sensing | 23 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Incorrect Measurement | 1 | Device |
| 2022 | Incorrect Interpretation of Signal | 2 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 5 | Device |
| 2022 | Inappropriate or Unexpected Reset | 5 | Device |
| 2022 | Failure to Interrogate | 2 | Device |
| 2022 | Failure to Charge | 1 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Environmental Compatibility Problem | 2 | Device |
| 2022 | Delayed Charge Time | 2 | Device |
| 2022 | Capturing Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2021 | Over-Sensing | 1 | Device |
| 2021 | Failure to Charge | 1 | Device |
| 2020 | Discomfort | 1 | Patient |
| 2020 | Over-Sensing | 1 | Device |
| 2019 | Wireless Communication Problem | 2 | Device |
| 2019 | Under-Sensing | 7 | Device |
| 2019 | Telemetry Discrepancy | 1 | Device |
| 2019 | Signal Artifact/Noise | 10 | Device |
| 2019 | Premature Discharge of Battery | 2 | Device |
| 2019 | Pacing Problem | 1 | Device |
| 2019 | Over-Sensing | 83 | Device |
| 2019 | Output Problem | 2 | Device |
| 2019 | No Pacing | 1 | Device |
| 2019 | Misconnection | 4 | Device |
| 2019 | Migration | 1 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Loose or Intermittent Connection | 2 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2019 | Incorrect Measurement | 1 | Device |
| 2019 | Incorrect Interpretation of Signal | 7 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 20 | Device |
| 2019 | Inappropriate or Unexpected Reset | 30 | Device |
| 2019 | High impedance | 1 | Device |
| 2019 | High Capture Threshold | 1 | Device |
| 2019 | Failure to Deliver Shock/Stimulation | 5 | Device |
| 2019 | Failure to Convert Rhythm | 2 | Device |
| 2019 | Failure to Charge | 2 | Device |
| 2019 | Failure to Capture | 4 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2019 | Delayed Charge Time | 2 | Device |
| 2019 | Defective Alarm | 1 | Device |
| 2019 | Data Problem | 6 | Device |
| 2019 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2019 | Connection Problem | 1 | Device |
| 2019 | Communication or Transmission Problem | 5 | Device |
| 2019 | Appropriate Term/Code Not Available | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 39 | Device |
| 2018 | Unstable Capture Threshold | 1 | Device |
| 2018 | Under-Sensing | 6 | Device |
| 2018 | Telemetry Discrepancy | 1 | Device |
| 2018 | Signal Artifact/Noise | 13 | Device |
| 2018 | Premature Discharge of Battery | 1 | Device |
| 2018 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2018 | Over-Sensing | 100 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | Operating System Version or Upgrade Problem | 1 | Device |
| 2018 | Misconnection | 2 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Low impedance | 2 | Device |
| 2018 | Incorrect Interpretation of Signal | 9 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 22 | Device |
| 2018 | Inappropriate or Unexpected Reset | 41 | Device |
| 2018 | Impedance Problem | 1 | Device |
| 2018 | High impedance | 3 | Device |
| 2018 | High Capture Threshold | 1 | Device |
| 2018 | Failure to Deliver Shock/Stimulation | 4 | Device |
| 2018 | Failure to Charge | 3 | Device |
| 2018 | Failure to Capture | 4 | Device |
| 2018 | Energy Output Problem | 1 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 2 | Device |
| 2018 | Delayed Charge Time | 6 | Device |
| 2018 | Defibrillation/Stimulation Problem | 5 | Device |
| 2018 | Decreased Sensitivity | 2 | Device |
| 2018 | Data Problem | 6 | Device |
| 2018 | Connection Problem | 3 | Device |
| 2018 | Communication or Transmission Problem | 12 | Device |
| 2018 | Appropriate Term/Code Not Available | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 51 | Device |
| 2017 | Wireless Communication Problem | 1 | Device |
| 2017 | Under-Sensing | 4 | Device |
| 2017 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2017 | Signal Artifact/Noise | 3 | Device |
| 2017 | Programming Issue | 4 | Device |
| 2017 | Premature Discharge of Battery | 3 | Device |
| 2017 | Pacing Problem | 3 | Device |
| 2017 | Pacing Inadequately | 1 | Device |
| 2017 | Pacemaker Found in Back-Up Mode | 5 | Device |
| 2017 | Over-Sensing | 89 | Device |
| 2017 | Output Problem | 3 | Device |
| 2017 | No Device Output | 1 | Device |
| 2017 | Misconnection | 1 | Device |
| 2017 | Migration or Expulsion of Device | 4 | Device |
| 2017 | Intermittent Capture | 1 | Device |
| 2017 | Incorrect Interpretation of Signal | 2 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 24 | Device |
| 2017 | Inappropriate or Unexpected Reset | 33 | Device |
| 2017 | Impedance Problem | 1 | Device |
| 2017 | High impedance | 3 | Device |
| 2017 | Failure to Sense | 1 | Device |
| 2017 | Failure to Interrogate | 4 | Device |
| 2017 | Failure to Disconnect | 1 | Device |
| 2017 | Failure to Capture | 4 | Device |
| 2017 | Electromagnetic Interference | 1 | Device |
| 2017 | Difficult to Remove | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 12 | Device |
| 2017 | Device Displays Incorrect Message | 2 | Device |
| 2017 | Detachment of Device or Device Component | 1 | Device |
| 2017 | Delayed Charge Time | 7 | Device |
| 2017 | Defibrillation/Stimulation Problem | 3 | Device |
| 2017 | Decreased Sensitivity | 1 | Device |
| 2017 | Communication or Transmission Problem | 2 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2016 | Under-Sensing | 6 | Device |
| 2016 | Positioning Failure | 1 | Device |
| 2016 | Pacing Problem | 3 | Device |
| 2016 | Over-Sensing | 49 | Device |
| 2016 | Output Problem | 1 | Device |
| 2016 | Intermittent Capture | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 12 | Device |
| 2016 | Inappropriate or Unexpected Reset | 11 | Device |
| 2016 | Improper Device Output | 1 | Device |
| 2016 | High impedance | 1 | Device |
| 2016 | High Capture Threshold | 2 | Device |
| 2016 | Failure to Interrogate | 1 | Device |
| 2016 | Failure to Convert Rhythm | 1 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 7 | Device |
| 2016 | Delayed Charge Time | 1 | Device |
| 2016 | Defibrillation/Stimulation Problem | 2 | Device |
| 2016 | Decreased Sensitivity | 2 | Device |
| 2016 | Connection Problem | 1 | Device |
| 2016 | Charging Problem | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2015 | Under-Sensing | 1 | Device |
| 2015 | Over-Sensing | 3 | Device |
| 2015 | Inappropriate or Unexpected Reset | 2 | Device |
| 2015 | Device Operates Differently Than Expected | 2 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2014 | Nonstandard Device | 1 | Device |
| 2014 | Insufficient Information | 1 | Device |