PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
This device is manufactured by BOSTON SCIENTIFIC, BOSTON SCIENTIFIC CORPORATION, GUIDANT CRM CLONMEL IRELAND.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 7 | Patient |
| 2024 | Undesired Nerve Stimulation | 1 | Patient |
| 2024 | Syncope/Fainting | 6 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Presyncope | 2 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Paresthesia | 1 | Patient |
| 2024 | Pain | 4 | Patient |
| 2024 | Fall | 2 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Discomfort | 3 | Patient |
| 2024 | Device Overstimulation of Tissue | 5 | Patient |
| 2024 | Bradycardia | 5 | Patient |
| 2024 | Bone Fracture(s) | 1 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Asystole | 4 | Patient |
| 2024 | Under-Sensing | 3 | Device |
| 2024 | Signal Artifact/Noise | 1 | Device |
| 2024 | Premature Discharge of Battery | 6 | Device |
| 2024 | Pacing Problem | 8 | Device |
| 2024 | Over-Sensing | 6 | Device |
| 2024 | Off-Label Use | 1 | Device |
| 2024 | Interrogation Problem | 2 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 18 | Device |
| 2024 | Inappropriate or Unexpected Reset | 2 | Device |
| 2024 | High Capture Threshold | 1 | Device |
| 2024 | Failure to Read Input Signal | 1 | Device |
| 2024 | Failure to Capture | 3 | Device |
| 2024 | Defective Device | 3 | Device |
| 2024 | Battery Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2023 | Unspecified Infection | 6 | Patient |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Syncope/Fainting | 2 | Patient |
| 2023 | Presyncope | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Malaise | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Fall | 2 | Patient |
| 2023 | Discomfort | 3 | Patient |
| 2023 | Device Overstimulation of Tissue | 7 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Bradycardia | 1 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Under-Sensing | 1 | Device |
| 2023 | Telemetry Discrepancy | 1 | Device |
| 2023 | Signal Artifact/Noise | 6 | Device |
| 2023 | Premature Discharge of Battery | 4 | Device |
| 2023 | Pacing Problem | 8 | Device |
| 2023 | Over-Sensing | 13 | Device |
| 2023 | Off-Label Use | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 19 | Device |
| 2023 | Inappropriate or Unexpected Reset | 4 | Device |
| 2023 | High impedance | 6 | Device |
| 2023 | High Capture Threshold | 1 | Device |
| 2023 | Failure to Read Input Signal | 1 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Data Problem | 1 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2022 | Dyspnea | 1 | Patient |
| 2022 | Chest Pain | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Signal Artifact/Noise | 11 | Device |
| 2022 | Premature Discharge of Battery | 5 | Device |
| 2022 | Pacing Problem | 6 | Device |
| 2022 | Over-Sensing | 11 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Interrogation Problem | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 5 | Device |
| 2022 | Inappropriate or Unexpected Reset | 1 | Device |
| 2022 | High impedance | 12 | Device |
| 2022 | High Capture Threshold | 2 | Device |
| 2022 | Failure to Read Input Signal | 1 | Device |
| 2022 | Failure to Capture | 3 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Battery Problem | 5 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Premature Discharge of Battery | 1 | Device |
| 2021 | Over-Sensing | 2 | Device |
| 2021 | High impedance | 2 | Device |
| 2021 | Connection Problem | 1 | Device |
| 2020 | Unspecified Infection | 1 | Patient |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Atrial Fibrillation | 1 | Patient |
| 2020 | Signal Artifact/Noise | 1 | Device |
| 2020 | High impedance | 2 | Device |
| 2020 | Failure to Capture | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Insufficient Information | 1 | Patient |
| 2019 | Unintended Electrical Shock | 1 | Device |
| 2019 | Under-Sensing | 1 | Device |
| 2019 | Signal Artifact/Noise | 2 | Device |
| 2019 | Premature Discharge of Battery | 3 | Device |
| 2019 | Patient-Device Incompatibility | 3 | Device |
| 2019 | Pacing Problem | 6 | Device |
| 2019 | Over-Sensing | 14 | Device |
| 2019 | Off-Label Use | 3 | Device |
| 2019 | Interrogation Problem | 1 | Device |
| 2019 | Impedance Problem | 1 | Device |
| 2019 | High impedance | 22 | Device |
| 2019 | High Capture Threshold | 2 | Device |
| 2019 | Failure to Sense | 1 | Device |
| 2019 | Failure to Capture | 4 | Device |
| 2019 | Device Sensing Problem | 11 | Device |
| 2019 | Device Displays Incorrect Message | 2 | Device |
| 2019 | Defective Device | 5 | Device |
| 2019 | Data Problem | 1 | Device |
| 2019 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2018 | Insufficient Information | 1 | Patient |
| 2018 | Use of Device Problem | 6 | Device |
| 2018 | Signal Artifact/Noise | 4 | Device |
| 2018 | Premature Discharge of Battery | 6 | Device |
| 2018 | Pocket Stimulation | 5 | Device |
| 2018 | Pacing Problem | 14 | Device |
| 2018 | Over-Sensing | 23 | Device |
| 2018 | Off-Label Use | 1 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Low impedance | 5 | Device |
| 2018 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2018 | Impedance Problem | 7 | Device |
| 2018 | High impedance | 55 | Device |
| 2018 | High Capture Threshold | 2 | Device |
| 2018 | Failure to Capture | 10 | Device |
| 2018 | Device Sensing Problem | 17 | Device |
| 2018 | Device Operates Differently Than Expected | 6 | Device |
| 2018 | Device Displays Incorrect Message | 4 | Device |
| 2018 | Defective Device | 7 | Device |
| 2018 | Capturing Problem | 2 | Device |
| 2018 | Ambient Noise Problem | 17 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 55 | Device |
| 2017 | Use of Device Problem | 14 | Device |
| 2017 | Under-Sensing | 1 | Device |
| 2017 | Signal Artifact/Noise | 2 | Device |
| 2017 | Premature Discharge of Battery | 9 | Device |
| 2017 | Pocket Stimulation | 3 | Device |
| 2017 | Pacing Problem | 21 | Device |
| 2017 | Over-Sensing | 37 | Device |
| 2017 | Migration or Expulsion of Device | 2 | Device |
| 2017 | Material Integrity Problem | 2 | Device |
| 2017 | Low impedance | 4 | Device |
| 2017 | Impedance Problem | 2 | Device |
| 2017 | High impedance | 50 | Device |
| 2017 | Fitting Problem | 2 | Device |
| 2017 | Failure to Capture | 5 | Device |
| 2017 | Device Sensing Problem | 3 | Device |
| 2017 | Device Operates Differently Than Expected | 25 | Device |
| 2017 | Device Displays Incorrect Message | 5 | Device |
| 2017 | Device Contamination With Biological Material | 1 | Device |
| 2017 | Connection Problem | 2 | Device |
| 2017 | Component Falling | 1 | Device |
| 2017 | Communication or Transmission Problem | 3 | Device |
| 2017 | Capturing Problem | 1 | Device |
| 2017 | Ambient Noise Problem | 36 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 53 | Device |
| 2016 | Use of Device Problem | 7 | Device |
| 2016 | Under-Sensing | 1 | Device |
| 2016 | Signal Artifact/Noise | 1 | Device |
| 2016 | Premature Discharge of Battery | 2 | Device |
| 2016 | Pocket Stimulation | 4 | Device |
| 2016 | Pacing Problem | 11 | Device |
| 2016 | Over-Sensing | 16 | Device |
| 2016 | Low impedance | 3 | Device |
| 2016 | Impedance Problem | 4 | Device |
| 2016 | High impedance | 17 | Device |
| 2016 | Failure to Capture | 3 | Device |
| 2016 | Electrical /Electronic Property Problem | 1 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 5 | Device |
| 2016 | Device Displays Incorrect Message | 1 | Device |
| 2016 | Defibrillation/Stimulation Problem | 1 | Device |
| 2016 | Defective Device | 1 | Device |
| 2016 | Capturing Problem | 6 | Device |
| 2016 | Ambient Noise Problem | 15 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 36 | Device |