IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
This device is manufactured by ABBOTT MEDICAL / ST JUDE MEDICAL, ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL - NEUROMODULATION (PUERTO RICO ) and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 1 | Patient |
| 2024 | Valvular Insufficiency/ Regurgitation | 1 | Patient |
| 2024 | Unspecified Infection | 3 | Patient |
| 2024 | Insufficient Information | 9 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Under-Sensing | 2 | Device |
| 2024 | Tactile Prompts/Feedback | 1 | Device |
| 2024 | Signal Artifact/Noise | 2 | Device |
| 2024 | Premature Discharge of Battery | 22 | Device |
| 2024 | Over-Sensing | 3 | Device |
| 2024 | Migration or Expulsion of Device | 2 | Device |
| 2024 | Interrogation Problem | 3 | Device |
| 2024 | Incorrect Measurement | 2 | Device |
| 2024 | Incorrect Interpretation of Signal | 5 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2024 | Inappropriate or Unexpected Reset | 9 | Device |
| 2024 | Failure to Sense | 1 | Device |
| 2024 | Failure to Interrogate | 5 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 2 | Device |
| 2024 | Failure to Convert Rhythm | 2 | Device |
| 2024 | Failure to Charge | 1 | Device |
| 2024 | Failure to Capture | 2 | Device |
| 2024 | Environmental Compatibility Problem | 5 | Device |
| 2024 | Device Sensing Problem | 1 | Device |
| 2024 | Delayed Charge Time | 1 | Device |
| 2024 | Defective Device | 1 | Device |
| 2024 | Component Missing | 1 | Device |
| 2024 | Compatibility Problem | 1 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2023 | Unspecified Infection | 8 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Insufficient Information | 4 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Discomfort | 3 | Patient |
| 2023 | Arrhythmia | 2 | Patient |
| 2023 | Under-Sensing | 3 | Device |
| 2023 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2023 | Premature Discharge of Battery | 23 | Device |
| 2023 | Pacing Problem | 1 | Device |
| 2023 | Over-Sensing | 11 | Device |
| 2023 | No Apparent Adverse Event | 1 | Device |
| 2023 | Migration or Expulsion of Device | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Incorrect Measurement | 1 | Device |
| 2023 | Incorrect Interpretation of Signal | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2023 | Inappropriate or Unexpected Reset | 7 | Device |
| 2023 | High impedance | 2 | Device |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Failure to Deliver Shock/Stimulation | 1 | Device |
| 2023 | Failure to Convert Rhythm | 1 | Device |
| 2023 | Failure to Charge | 1 | Device |
| 2023 | Environmental Compatibility Problem | 3 | Device |
| 2023 | Delayed Charge Time | 1 | Device |
| 2023 | Defective Device | 4 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2023 | Charging Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Failure of Implant | 1 | Patient |
| 2022 | Arrhythmia | 1 | Patient |
| 2022 | Wireless Communication Problem | 1 | Device |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Signal Artifact/Noise | 3 | Device |
| 2022 | Premature Discharge of Battery | 30 | Device |
| 2022 | Pacing Asynchronously | 1 | Device |
| 2022 | Over-Sensing | 7 | Device |
| 2022 | Intermittent Capture | 1 | Device |
| 2022 | Incorrect Measurement | 1 | Device |
| 2022 | Incorrect Interpretation of Signal | 5 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2022 | Inappropriate or Unexpected Reset | 7 | Device |
| 2022 | Failure to Interrogate | 7 | Device |
| 2022 | Failure to Deliver Shock/Stimulation | 3 | Device |
| 2022 | Failure to Convert Rhythm | 3 | Device |
| 2022 | Environmental Compatibility Problem | 1 | Device |
| 2022 | Delayed Charge Time | 1 | Device |
| 2022 | Defective Device | 3 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2021 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2021 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2021 | Dyspnea | 1 | Patient |
| 2021 | Arrhythmia | 1 | Patient |
| 2021 | Incorrect Interpretation of Signal | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2021 | Failure to Convert Rhythm | 1 | Device |
| 2020 | Premature Discharge of Battery | 1 | Device |
| 2020 | Inappropriate or Unexpected Reset | 1 | Device |
| 2020 | Failure to Interrogate | 1 | Device |