IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
This device is manufactured by BOSTON SCIENTIFIC CORPORATION, GUIDANT CRM CLONMEL IRELAND.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Ventricular Fibrillation | 2 | Patient |
| 2024 | Unspecified Infection | 3 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Shock from Patient Lead(s) | 17 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Fatigue | 2 | Patient |
| 2024 | Electric Shock | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Asystole | 1 | Patient |
| 2024 | Arrhythmia | 2 | Patient |
| 2024 | Unexpected Therapeutic Results | 2 | Device |
| 2024 | Under-Sensing | 2 | Device |
| 2024 | Signal Artifact/Noise | 1 | Device |
| 2024 | Premature Discharge of Battery | 5 | Device |
| 2024 | Pacing Problem | 10 | Device |
| 2024 | Over-Sensing | 6 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 16 | Device |
| 2024 | Inaccurate Synchronization | 5 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | Failure to Convert Rhythm | 1 | Device |
| 2024 | Defective Device | 1 | Device |
| 2024 | Data Problem | 1 | Device |
| 2024 | Battery Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2023 | Unspecified Infection | 3 | Patient |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 1 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Presyncope | 1 | Patient |
| 2023 | Electric Shock | 6 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Atrial Fibrillation | 1 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Arrhythmia | 3 | Patient |
| 2023 | Under-Sensing | 7 | Device |
| 2023 | Signal Artifact/Noise | 4 | Device |
| 2023 | Premature Discharge of Battery | 14 | Device |
| 2023 | Patient-Device Incompatibility | 1 | Device |
| 2023 | Pacing Problem | 10 | Device |
| 2023 | Over-Sensing | 8 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | Low impedance | 2 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2023 | Inaccurate Synchronization | 4 | Device |
| 2023 | High impedance | 9 | Device |
| 2023 | Failure to Read Input Signal | 2 | Device |
| 2023 | Failure to Convert Rhythm | 1 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Data Problem | 2 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Unspecified Heart Problem | 1 | Patient |
| 2022 | Arrhythmia | 1 | Patient |
| 2022 | Unexpected Therapeutic Results | 1 | Device |
| 2022 | Under-Sensing | 3 | Device |
| 2022 | Signal Artifact/Noise | 3 | Device |
| 2022 | Premature Discharge of Battery | 5 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Over-Sensing | 7 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2022 | Inaccurate Synchronization | 2 | Device |
| 2022 | Impedance Problem | 1 | Device |
| 2022 | High impedance | 8 | Device |
| 2022 | High Capture Threshold | 1 | Device |
| 2022 | Failure to Capture | 2 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Electric Shock | 1 | Patient |
| 2021 | Atrial Fibrillation | 1 | Patient |
| 2021 | Appropriate Term / Code Not Available | 1 | Patient |
| 2021 | Signal Artifact/Noise | 2 | Device |
| 2021 | Over-Sensing | 3 | Device |
| 2021 | Off-Label Use | 1 | Device |
| 2021 | Interrogation Problem | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2021 | Inaccurate Synchronization | 1 | Device |
| 2021 | High impedance | 2 | Device |
| 2020 | Under-Sensing | 1 | Device |
| 2020 | Pacing Problem | 1 | Device |
| 2020 | Over-Sensing | 1 | Device |
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2020 | Inaccurate Synchronization | 1 | Device |
| 2019 | Shock from Patient Lead(s) | 1 | Patient |
| 2019 | Electric Shock | 1 | Patient |
| 2019 | Unintended Electrical Shock | 1 | Device |
| 2019 | Unexpected Therapeutic Results | 2 | Device |
| 2019 | Signal Artifact/Noise | 1 | Device |
| 2019 | Patient-Device Incompatibility | 1 | Device |
| 2019 | Pacing Problem | 7 | Device |
| 2019 | Over-Sensing | 11 | Device |
| 2019 | Off-Label Use | 1 | Device |
| 2019 | Noise, Audible | 1 | Device |
| 2019 | Migration | 1 | Device |
| 2019 | Interrogation Problem | 1 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 9 | Device |
| 2019 | Inaccurate Synchronization | 1 | Device |
| 2019 | Impedance Problem | 1 | Device |
| 2019 | High impedance | 21 | Device |
| 2019 | High Capture Threshold | 2 | Device |
| 2019 | Failure to Convert Rhythm | 2 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Device Sensing Problem | 6 | Device |
| 2019 | Device Displays Incorrect Message | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 1 | Device |
| 2019 | Defective Device | 3 | Device |
| 2019 | Data Problem | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 40 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Unintended Electrical Shock | 2 | Device |
| 2018 | Unexpected Therapeutic Results | 4 | Device |
| 2018 | Under-Sensing | 3 | Device |
| 2018 | Signal Artifact/Noise | 2 | Device |
| 2018 | Protective Measures Problem | 1 | Device |
| 2018 | Pocket Stimulation | 1 | Device |
| 2018 | Pacing Problem | 17 | Device |
| 2018 | Over-Sensing | 33 | Device |
| 2018 | Migration | 1 | Device |
| 2018 | Material Integrity Problem | 2 | Device |
| 2018 | Low impedance | 6 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 13 | Device |
| 2018 | Inappropriate or Unexpected Reset | 1 | Device |
| 2018 | Impedance Problem | 6 | Device |
| 2018 | High impedance | 53 | Device |
| 2018 | High Capture Threshold | 4 | Device |
| 2018 | Fitting Problem | 1 | Device |
| 2018 | Failure to Select Signal | 3 | Device |
| 2018 | Failure to Read Input Signal | 1 | Device |
| 2018 | Failure to Convert Rhythm | 2 | Device |
| 2018 | Failure to Capture | 5 | Device |
| 2018 | Device Sensing Problem | 14 | Device |
| 2018 | Device Operates Differently Than Expected | 8 | Device |
| 2018 | Device Displays Incorrect Message | 6 | Device |
| 2018 | Device Alarm System | 3 | Device |
| 2018 | Defibrillation/Stimulation Problem | 1 | Device |
| 2018 | Defective Device | 6 | Device |
| 2018 | Connection Problem | 1 | Device |
| 2018 | Communication or Transmission Problem | 3 | Device |
| 2018 | Capturing Problem | 4 | Device |
| 2018 | Ambient Noise Problem | 22 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 63 | Device |
| 2017 | Under-Sensing | 4 | Device |
| 2017 | Premature Discharge of Battery | 2 | Device |
| 2017 | Pocket Stimulation | 1 | Device |
| 2017 | Pacing Problem | 10 | Device |
| 2017 | Over-Sensing | 36 | Device |
| 2017 | No Audible Alarm | 1 | Device |
| 2017 | Material Integrity Problem | 2 | Device |
| 2017 | Low impedance | 12 | Device |
| 2017 | Loose or Intermittent Connection | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 11 | Device |
| 2017 | Impedance Problem | 2 | Device |
| 2017 | High impedance | 52 | Device |
| 2017 | Fitting Problem | 5 | Device |
| 2017 | Failure to Convert Rhythm | 3 | Device |
| 2017 | Failure to Capture | 9 | Device |
| 2017 | Electrical /Electronic Property Problem | 5 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Device Sensing Problem | 8 | Device |
| 2017 | Device Operates Differently Than Expected | 13 | Device |
| 2017 | Device Displays Incorrect Message | 6 | Device |
| 2017 | Device Alarm System | 4 | Device |
| 2017 | Connection Problem | 3 | Device |
| 2017 | Communication or Transmission Problem | 3 | Device |
| 2017 | Capturing Problem | 3 | Device |
| 2017 | Ambient Noise Problem | 36 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 62 | Device |
| 2016 | Premature Discharge of Battery | 3 | Device |
| 2016 | Pacing Problem | 4 | Device |
| 2016 | Over-Sensing | 14 | Device |
| 2016 | Migration or Expulsion of Device | 1 | Device |
| 2016 | Material Integrity Problem | 1 | Device |
| 2016 | Low impedance | 4 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2016 | Impedance Problem | 3 | Device |
| 2016 | High impedance | 22 | Device |
| 2016 | Fitting Problem | 3 | Device |
| 2016 | Electrical /Electronic Property Problem | 4 | Device |
| 2016 | Device Sensing Problem | 2 | Device |
| 2016 | Device Operates Differently Than Expected | 14 | Device |
| 2016 | Device Displays Incorrect Message | 1 | Device |
| 2016 | Device Contamination With Biological Material | 1 | Device |
| 2016 | Device Alarm System | 5 | Device |
| 2016 | Defibrillation/Stimulation Problem | 2 | Device |
| 2016 | Connection Problem | 3 | Device |
| 2016 | Capturing Problem | 2 | Device |
| 2016 | Ambient Noise Problem | 14 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 27 | Device |