IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
This device is manufactured by ST JUDE MEDICAL, 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 | Unspecified Infection | 9 | Patient |
2024 | Syncope/Fainting | 1 | Patient |
2024 | Pocket Erosion | 4 | Patient |
2024 | Pericardial Effusion | 1 | Patient |
2024 | Insufficient Information | 4 | Patient |
2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
2024 | Hematoma | 1 | Patient |
2024 | Discomfort | 6 | Patient |
2024 | Arrhythmia | 8 | Patient |
2024 | Use of Device Problem | 1 | Device |
2024 | Under-Sensing | 4 | Device |
2024 | Premature Discharge of Battery | 6 | Device |
2024 | Pacing Problem | 5 | Device |
2024 | Pacing Asynchronously | 2 | Device |
2024 | Over-Sensing | 28 | Device |
2024 | No Pacing | 1 | Device |
2024 | No Apparent Adverse Event | 1 | Device |
2024 | Migration or Expulsion of Device | 1 | Device |
2024 | Low impedance | 2 | Device |
2024 | Loose or Intermittent Connection | 1 | Device |
2024 | Interrogation Problem | 1 | Device |
2024 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
2024 | Incorrect Measurement | 2 | Device |
2024 | Incorrect Interpretation of Signal | 2 | Device |
2024 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
2024 | Inappropriate or Unexpected Reset | 5 | 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 | 1 | Device |
2024 | Environmental Compatibility Problem | 1 | Device |
2024 | Data Problem | 1 | Device |
2024 | Capturing Problem | 1 | Device |
2024 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
2023 | Unspecified Infection | 11 | Patient |
2023 | Pocket Erosion | 5 | Patient |
2023 | Insufficient Information | 8 | Patient |
2023 | Dyspnea | 1 | Patient |
2023 | Dizziness | 1 | Patient |
2023 | Discomfort | 4 | Patient |
2023 | Arrhythmia | 7 | Patient |
2023 | Under-Sensing | 7 | Device |
2023 | Tactile Prompts/Feedback | 1 | Device |
2023 | Signal Artifact/Noise | 3 | Device |
2023 | Product Quality Problem | 1 | Device |
2023 | Premature Discharge of Battery | 17 | Device |
2023 | Pacing Problem | 6 | Device |
2023 | Pacing Asynchronously | 3 | Device |
2023 | Over-Sensing | 64 | Device |
2023 | No Pacing | 1 | Device |
2023 | No Apparent Adverse Event | 2 | Device |
2023 | Migration or Expulsion of Device | 1 | Device |
2023 | Loose or Intermittent Connection | 1 | Device |
2023 | Interrogation Problem | 1 | Device |
2023 | Intermittent Capture | 2 | Device |
2023 | Insufficient Information | 1 | Device |
2023 | Incorrect Measurement | 2 | Device |
2023 | Incorrect Interpretation of Signal | 16 | Device |
2023 | Inappropriate/Inadequate Shock/Stimulation | 20 | Device |
2023 | Inappropriate or Unexpected Reset | 9 | Device |
2023 | High impedance | 3 | Device |
2023 | Failure to Interrogate | 4 | Device |
2023 | Failure to Disconnect | 1 | Device |
2023 | Failure to Deliver Shock/Stimulation | 2 | Device |
2023 | Failure to Convert Rhythm | 2 | Device |
2023 | Failure to Capture | 1 | Device |
2023 | Environmental Compatibility Problem | 1 | Device |
2023 | Device Sensing Problem | 1 | Device |
2023 | Delayed Charge Time | 2 | Device |
2023 | Connection Problem | 1 | Device |
2023 | Capturing Problem | 2 | Device |
2023 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
2022 | Syncope/Fainting | 1 | Patient |
2022 | Pocket Erosion | 1 | Patient |
2022 | Insufficient Information | 1 | Patient |
2022 | Failure of Implant | 1 | Patient |
2022 | Arrhythmia | 2 | Patient |
2022 | Under-Sensing | 9 | Device |
2022 | Tactile Prompts/Feedback | 1 | Device |
2022 | Signal Artifact/Noise | 2 | Device |
2022 | Premature Discharge of Battery | 27 | Device |
2022 | Pacing Problem | 6 | Device |
2022 | Over-Sensing | 48 | Device |
2022 | No Apparent Adverse Event | 2 | Device |
2022 | Interrogation Problem | 1 | Device |
2022 | Intermittent Capture | 1 | Device |
2022 | Insufficient Information | 3 | Device |
2022 | Incorrect Measurement | 1 | Device |
2022 | Incorrect Interpretation of Signal | 13 | Device |
2022 | Inappropriate/Inadequate Shock/Stimulation | 17 | Device |
2022 | Inappropriate or Unexpected Reset | 7 | Device |
2022 | High impedance | 3 | Device |
2022 | Failure to Interrogate | 8 | Device |
2022 | Failure to Deliver Shock/Stimulation | 2 | Device |
2022 | Failure to Convert Rhythm | 3 | Device |
2022 | Failure to Capture | 1 | Device |
2022 | Environmental Compatibility Problem | 1 | Device |
2022 | Device Sensing Problem | 2 | Device |
2022 | Defective Device | 3 | Device |
2022 | Defective Component | 1 | Device |
2022 | Data Problem | 2 | Device |
2022 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
2021 | Insufficient Information | 1 | Patient |
2021 | Premature Discharge of Battery | 1 | Device |
2021 | Insufficient Information | 1 | Device |
2021 | High impedance | 1 | Device |
2021 | Failure to Deliver Shock/Stimulation | 1 | Device |
2021 | Device Sensing Problem | 1 | Device |
2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |