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 | 6 | Patient |
| 2024 | Shock from Patient Lead(s) | 14 | Patient |
| 2024 | Pocket Erosion | 2 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Electric Shock | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Burning Sensation | 1 | Patient |
| 2024 | Bacterial Infection | 3 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Unexpected Therapeutic Results | 2 | Device |
| 2024 | Under-Sensing | 4 | Device |
| 2024 | Signal Artifact/Noise | 4 | Device |
| 2024 | Premature Discharge of Battery | 16 | Device |
| 2024 | Pacing Problem | 13 | Device |
| 2024 | Over-Sensing | 10 | Device |
| 2024 | Off-Label Use | 1 | Device |
| 2024 | Noise, Audible | 2 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Interrogation Problem | 2 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 13 | Device |
| 2024 | Inaccurate Synchronization | 2 | Device |
| 2024 | Impedance Problem | 1 | Device |
| 2024 | High impedance | 12 | Device |
| 2024 | High Capture Threshold | 2 | Device |
| 2024 | Failure to Read Input Signal | 1 | Device |
| 2024 | Failure to Convert Rhythm | 1 | Device |
| 2024 | Failure to Capture | 2 | Device |
| 2024 | Delayed Charge Time | 1 | Device |
| 2024 | Defective Device | 3 | Device |
| 2024 | Data Problem | 1 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Battery Problem | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Ventricular Fibrillation | 2 | Patient |
| 2023 | Unspecified Infection | 14 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 2 | Patient |
| 2023 | Shock from Patient Lead(s) | 2 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Electric Shock | 8 | Patient |
| 2023 | Diaphoresis | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Arrhythmia | 2 | Patient |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Unexpected Therapeutic Results | 1 | Device |
| 2023 | Under-Sensing | 4 | Device |
| 2023 | Telemetry Discrepancy | 1 | Device |
| 2023 | Signal Artifact/Noise | 4 | Device |
| 2023 | Premature Discharge of Battery | 12 | Device |
| 2023 | Pacing Problem | 14 | Device |
| 2023 | Over-Sensing | 16 | Device |
| 2023 | Off-Label Use | 1 | Device |
| 2023 | Noise, Audible | 3 | Device |
| 2023 | No Audible Alarm | 1 | Device |
| 2023 | Low impedance | 2 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 3 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 9 | Device |
| 2023 | Inaccurate Synchronization | 4 | Device |
| 2023 | High impedance | 11 | Device |
| 2023 | High Capture Threshold | 1 | Device |
| 2023 | Failure to Convert Rhythm | 2 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Defibrillation/Stimulation Problem | 1 | Device |
| 2023 | Defective Device | 1 | Device |
| 2023 | Data Problem | 1 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 16 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Electric Shock | 4 | Patient |
| 2022 | Unexpected Therapeutic Results | 2 | Device |
| 2022 | Under-Sensing | 9 | Device |
| 2022 | Telemetry Discrepancy | 1 | Device |
| 2022 | Signal Artifact/Noise | 5 | Device |
| 2022 | Premature Discharge of Battery | 7 | Device |
| 2022 | Pacing Problem | 17 | Device |
| 2022 | Over-Sensing | 10 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | Migration | 2 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Interrogation Problem | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 5 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 15 | Device |
| 2022 | Inaccurate Synchronization | 4 | Device |
| 2022 | High impedance | 17 | Device |
| 2022 | High Capture Threshold | 4 | Device |
| 2022 | Failure to Read Input Signal | 1 | Device |
| 2022 | Failure to Convert Rhythm | 1 | Device |
| 2022 | Failure to Capture | 2 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Defibrillation/Stimulation Problem | 1 | Device |
| 2022 | Defective Device | 2 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2021 | Electric Shock | 1 | Patient |
| 2021 | Arrhythmia | 1 | Patient |
| 2021 | Unexpected Therapeutic Results | 1 | Device |
| 2021 | Under-Sensing | 3 | Device |
| 2021 | Signal Artifact/Noise | 4 | Device |
| 2021 | Pacing Problem | 4 | Device |
| 2021 | Over-Sensing | 8 | Device |
| 2021 | Noise, Audible | 1 | Device |
| 2021 | Migration | 1 | Device |
| 2021 | Low impedance | 2 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2021 | Inaccurate Synchronization | 1 | Device |
| 2021 | High impedance | 6 | Device |
| 2021 | High Capture Threshold | 1 | Device |
| 2021 | Failure to Read Input Signal | 3 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2021 | Defective Device | 1 | Device |
| 2021 | Connection Problem | 1 | Device |
| 2019 | Unintended Electrical Shock | 1 | Device |
| 2019 | Unexpected Therapeutic Results | 3 | Device |
| 2019 | Under-Sensing | 1 | Device |
| 2019 | Signal Artifact/Noise | 1 | Device |
| 2019 | Premature Discharge of Battery | 1 | Device |
| 2019 | Patient-Device Incompatibility | 1 | Device |
| 2019 | Pacing Problem | 8 | Device |
| 2019 | Over-Sensing | 12 | Device |
| 2019 | Off-Label Use | 2 | Device |
| 2019 | Noise, Audible | 1 | Device |
| 2019 | No Audible Alarm | 1 | Device |
| 2019 | Migration | 1 | Device |
| 2019 | Low impedance | 3 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2019 | Human-Device Interface Problem | 1 | Device |
| 2019 | High impedance | 26 | Device |
| 2019 | Failure to Convert Rhythm | 2 | Device |
| 2019 | Failure to Capture | 2 | Device |
| 2019 | Difficult to Insert | 1 | Device |
| 2019 | Device Sensing Problem | 6 | Device |
| 2019 | Device Displays Incorrect Message | 2 | Device |
| 2019 | Defibrillation/Stimulation Problem | 1 | Device |
| 2019 | Defective Device | 2 | Device |
| 2019 | Data Problem | 2 | Device |
| 2019 | Connection Problem | 4 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 25 | Device |
| 2018 | Unexpected Therapeutic Results | 3 | Device |
| 2018 | Under-Sensing | 2 | Device |
| 2018 | Signal Artifact/Noise | 2 | Device |
| 2018 | Protective Measures Problem | 1 | Device |
| 2018 | Premature Discharge of Battery | 1 | Device |
| 2018 | Pocket Stimulation | 1 | Device |
| 2018 | Patient-Device Incompatibility | 3 | Device |
| 2018 | Pacing Problem | 16 | Device |
| 2018 | Over-Sensing | 48 | Device |
| 2018 | Noise, Audible | 5 | Device |
| 2018 | Material Integrity Problem | 5 | Device |
| 2018 | Low impedance | 10 | Device |
| 2018 | Loose or Intermittent Connection | 1 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 12 | Device |
| 2018 | Impedance Problem | 7 | Device |
| 2018 | High impedance | 79 | Device |
| 2018 | High Capture Threshold | 4 | Device |
| 2018 | Fitting Problem | 1 | Device |
| 2018 | Failure to Sense | 2 | Device |
| 2018 | Failure to Select Signal | 1 | Device |
| 2018 | Failure to Convert Rhythm | 2 | Device |
| 2018 | Failure to Capture | 13 | Device |
| 2018 | Electrical /Electronic Property Problem | 4 | Device |
| 2018 | Difficult to Insert | 1 | Device |
| 2018 | Device Sensing Problem | 19 | Device |
| 2018 | Device Operates Differently Than Expected | 8 | Device |
| 2018 | Device Displays Incorrect Message | 7 | Device |
| 2018 | Device Contamination With Biological Material | 1 | Device |
| 2018 | Device Alarm System | 3 | Device |
| 2018 | Defibrillation/Stimulation Problem | 2 | Device |
| 2018 | Defective Device | 9 | Device |
| 2018 | Contamination /Decontamination Problem | 1 | Device |
| 2018 | Connection Problem | 6 | Device |
| 2018 | Communication or Transmission Problem | 3 | Device |
| 2018 | Capturing Problem | 7 | Device |
| 2018 | Ambient Noise Problem | 26 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 93 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Under-Sensing | 5 | Device |
| 2017 | Signal Artifact/Noise | 1 | Device |
| 2017 | Pocket Stimulation | 1 | Device |
| 2017 | Pacing Problem | 17 | Device |
| 2017 | Over-Sensing | 33 | Device |
| 2017 | Migration or Expulsion of Device | 2 | Device |
| 2017 | Material Integrity Problem | 1 | Device |
| 2017 | Low impedance | 6 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 10 | Device |
| 2017 | Improper Alarm | 1 | Device |
| 2017 | Impedance Problem | 5 | Device |
| 2017 | High impedance | 53 | Device |
| 2017 | High Capture Threshold | 2 | Device |
| 2017 | Fitting Problem | 1 | Device |
| 2017 | Failure to Select Signal | 1 | Device |
| 2017 | Failure to Convert Rhythm | 1 | Device |
| 2017 | Failure to Capture | 10 | Device |
| 2017 | Electrical /Electronic Property Problem | 7 | Device |
| 2017 | Device Sensing Problem | 4 | Device |
| 2017 | Device Operates Differently Than Expected | 17 | Device |
| 2017 | Device Displays Incorrect Message | 2 | Device |
| 2017 | Device Alarm System | 4 | Device |
| 2017 | Defibrillation/Stimulation Problem | 3 | Device |
| 2017 | Data Problem | 1 | Device |
| 2017 | Connection Problem | 5 | Device |
| 2017 | Communication or Transmission Problem | 2 | Device |
| 2017 | Capturing Problem | 4 | Device |
| 2017 | Ambient Noise Problem | 39 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 62 | Device |
| 2016 | Pacing Problem | 5 | Device |
| 2016 | Over-Sensing | 11 | Device |
| 2016 | Migration or Expulsion of Device | 1 | Device |
| 2016 | Low impedance | 4 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2016 | Impedance Problem | 1 | Device |
| 2016 | High impedance | 23 | Device |
| 2016 | Failure to Convert Rhythm | 1 | Device |
| 2016 | Failure to Capture | 1 | Device |
| 2016 | Electrical /Electronic Property Problem | 2 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 11 | Device |
| 2016 | Device Displays Incorrect Message | 2 | Device |
| 2016 | Device Alarm System | 3 | Device |
| 2016 | Connection Problem | 3 | Device |
| 2016 | Communication or Transmission Problem | 1 | Device |
| 2016 | Capturing Problem | 3 | Device |
| 2016 | Ambient Noise Problem | 13 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 20 | Device |
| 2015 | Pacing Problem | 1 | Device |
| 2015 | Over-Sensing | 1 | Device |
| 2015 | High impedance | 2 | Device |
| 2015 | Fitting Problem | 1 | Device |
| 2015 | Ambient Noise Problem | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |