IMPLANTABLE PULSE GENERATOR
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 | Weight Changes | 1 | Patient |
| 2024 | Unspecified Infection | 4 | Patient |
| 2024 | Unspecified Heart Problem | 2 | Patient |
| 2024 | Syncope/Fainting | 3 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 2 | Patient |
| 2024 | Loss of consciousness | 2 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Head Injury | 1 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Endocarditis | 1 | Patient |
| 2024 | Dizziness | 6 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 2 | Patient |
| 2024 | Bradycardia | 2 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Asystole | 3 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Under-Sensing | 4 | Device |
| 2024 | Telemetry Discrepancy | 1 | Device |
| 2024 | Signal Artifact/Noise | 7 | Device |
| 2024 | Premature Discharge of Battery | 36 | Device |
| 2024 | Pacing Problem | 10 | Device |
| 2024 | Over-Sensing | 11 | Device |
| 2024 | Off-Label Use | 1 | Device |
| 2024 | Material Integrity Problem | 1 | Device |
| 2024 | Interrogation Problem | 3 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 65 | Device |
| 2024 | Inappropriate or Unexpected Reset | 1 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | High Capture Threshold | 3 | Device |
| 2024 | Failure to Read Input Signal | 1 | Device |
| 2024 | Failure to Capture | 8 | Device |
| 2024 | Defective Device | 4 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Battery Problem | 11 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2023 | Unspecified Infection | 4 | Patient |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Syncope/Fainting | 13 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Presyncope | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Malaise | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Fall | 2 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Dizziness | 2 | Patient |
| 2023 | Discomfort | 2 | Patient |
| 2023 | Device Overstimulation of Tissue | 2 | Patient |
| 2023 | Convulsion/Seizure | 1 | Patient |
| 2023 | Concussion | 1 | Patient |
| 2023 | Bradycardia | 2 | Patient |
| 2023 | Atrial Fibrillation | 1 | Patient |
| 2023 | Asystole | 9 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Unexpected Therapeutic Results | 1 | Device |
| 2023 | Under-Sensing | 5 | Device |
| 2023 | Telemetry Discrepancy | 7 | Device |
| 2023 | Signal Artifact/Noise | 19 | Device |
| 2023 | Premature Discharge of Battery | 42 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Pacing Problem | 21 | Device |
| 2023 | Over-Sensing | 22 | Device |
| 2023 | Low impedance | 5 | Device |
| 2023 | Interrogation Problem | 5 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 86 | Device |
| 2023 | Inappropriate or Unexpected Reset | 1 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | Human-Device Interface Problem | 1 | Device |
| 2023 | High impedance | 4 | Device |
| 2023 | High Capture Threshold | 2 | Device |
| 2023 | Failure to Read Input Signal | 2 | Device |
| 2023 | Failure to Capture | 5 | Device |
| 2023 | Device Sensing Problem | 1 | Device |
| 2023 | Defective Device | 13 | Device |
| 2023 | Data Problem | 2 | Device |
| 2023 | Battery Problem | 14 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Fall | 1 | Patient |
| 2022 | Device Overstimulation of Tissue | 1 | Patient |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Telemetry Discrepancy | 2 | Device |
| 2022 | Signal Artifact/Noise | 8 | Device |
| 2022 | Premature Discharge of Battery | 42 | Device |
| 2022 | Pacing Problem | 13 | Device |
| 2022 | Over-Sensing | 11 | Device |
| 2022 | Off-Label Use | 3 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Interrogation Problem | 4 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 29 | Device |
| 2022 | Inappropriate or Unexpected Reset | 4 | Device |
| 2022 | Inaccurate Synchronization | 1 | Device |
| 2022 | Impedance Problem | 1 | Device |
| 2022 | High impedance | 9 | Device |
| 2022 | High Capture Threshold | 3 | Device |
| 2022 | Failure to Capture | 7 | Device |
| 2022 | Device Contaminated at the User Facility | 1 | Device |
| 2022 | Defective Device | 13 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Battery Problem | 26 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2021 | Under-Sensing | 1 | Device |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Premature Discharge of Battery | 2 | Device |
| 2021 | Over-Sensing | 4 | Device |
| 2021 | Low impedance | 1 | Device |
| 2021 | High impedance | 2 | Device |
| 2021 | Defective Device | 4 | Device |
| 2021 | Battery Problem | 2 | Device |