IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
This device is manufactured by BOSTON SCIENTIFIC, BOSTON SCIENTIFIC - CORK, BOSTON SCIENTIFIC CORPORATION, GUIDANT CRM CLONMEL IRELAND, UNKNOWN.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 1 | Patient |
| 2024 | Unspecified Infection | 91 | Patient |
| 2024 | Unspecified Heart Problem | 4 | Patient |
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Syncope/Fainting | 6 | Patient |
| 2024 | Swelling/ Edema | 2 | Patient |
| 2024 | Speech Disorder | 1 | Patient |
| 2024 | Sepsis | 6 | Patient |
| 2024 | Respiratory Failure | 1 | Patient |
| 2024 | Rash | 1 | Patient |
| 2024 | Purulent Discharge | 2 | Patient |
| 2024 | Presyncope | 2 | Patient |
| 2024 | Pocket Erosion | 3 | Patient |
| 2024 | Pain | 3 | Patient |
| 2024 | Obstruction/Occlusion | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Inflammation | 1 | Patient |
| 2024 | Implant Pain | 2 | Patient |
| 2024 | Impaired Healing | 2 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2024 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2024 | Hematoma | 4 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Headache | 1 | Patient |
| 2024 | Head Injury | 1 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Endocarditis | 3 | Patient |
| 2024 | Dyspnea | 7 | Patient |
| 2024 | Dizziness | 5 | Patient |
| 2024 | Discomfort | 7 | Patient |
| 2024 | Diaphoresis | 1 | Patient |
| 2024 | Chest Pain | 2 | Patient |
| 2024 | Cardiac Tamponade | 1 | Patient |
| 2024 | Burning Sensation | 1 | Patient |
| 2024 | Bradycardia | 3 | Patient |
| 2024 | Bacterial Infection | 7 | Patient |
| 2024 | Atrial Fibrillation | 2 | Patient |
| 2024 | Asystole | 12 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Anxiety | 1 | Patient |
| 2024 | Use of Device Problem | 1 | Device |
| 2024 | Under-Sensing | 45 | Device |
| 2024 | Telemetry Discrepancy | 1 | Device |
| 2024 | Signal Artifact/Noise | 50 | Device |
| 2024 | Premature Discharge of Battery | 36 | Device |
| 2024 | Pocket Stimulation | 1 | Device |
| 2024 | Pacing Problem | 49 | Device |
| 2024 | Over-Sensing | 90 | Device |
| 2024 | Off-Label Use | 2 | Device |
| 2024 | Migration | 2 | Device |
| 2024 | Low impedance | 8 | Device |
| 2024 | Interrogation Problem | 3 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 16 | Device |
| 2024 | Inappropriate or Unexpected Reset | 1 | Device |
| 2024 | Inaccurate Synchronization | 1 | Device |
| 2024 | Impedance Problem | 3 | Device |
| 2024 | High impedance | 28 | Device |
| 2024 | High Capture Threshold | 17 | Device |
| 2024 | False Positive Result | 1 | Device |
| 2024 | Failure to Read Input Signal | 26 | Device |
| 2024 | Failure to Capture | 21 | Device |
| 2024 | Difficult to Insert | 1 | Device |
| 2024 | Device Sensing Problem | 1 | Device |
| 2024 | Device Contaminated at the User Facility | 1 | Device |
| 2024 | Defective Device | 16 | Device |
| 2024 | Data Problem | 5 | Device |
| 2024 | Connection Problem | 6 | Device |
| 2024 | Communication or Transmission Problem | 3 | Device |
| 2024 | Battery Problem | 23 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 87 | Device |
| 2023 | Visual Disturbances | 1 | Patient |
| 2023 | Valvular Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Unspecified Infection | 47 | Patient |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Twiddlers Syndrome | 2 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 3 | Patient |
| 2023 | Sepsis | 2 | Patient |
| 2023 | Presyncope | 2 | Patient |
| 2023 | Pocket Erosion | 2 | Patient |
| 2023 | Pleural Effusion | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Loss of consciousness | 1 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Impaired Healing | 2 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Dizziness | 3 | Patient |
| 2023 | Discomfort | 2 | Patient |
| 2023 | Device Overstimulation of Tissue | 2 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Bradycardia | 3 | Patient |
| 2023 | Bacterial Infection | 4 | Patient |
| 2023 | Atrial Flutter | 2 | Patient |
| 2023 | Atrial Fibrillation | 2 | Patient |
| 2023 | Asystole | 5 | Patient |
| 2023 | Arrhythmia | 3 | Patient |
| 2023 | Under-Sensing | 30 | Device |
| 2023 | Signal Artifact/Noise | 34 | Device |
| 2023 | Premature Discharge of Battery | 45 | Device |
| 2023 | Pacing Problem | 30 | Device |
| 2023 | Over-Sensing | 69 | Device |
| 2023 | Off-Label Use | 2 | Device |
| 2023 | Migration | 3 | Device |
| 2023 | Low impedance | 12 | Device |
| 2023 | Interrogation Problem | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 7 | Device |
| 2023 | Inappropriate or Unexpected Reset | 1 | Device |
| 2023 | Inaccurate Synchronization | 2 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | High impedance | 30 | Device |
| 2023 | High Capture Threshold | 11 | Device |
| 2023 | Failure to Sense | 1 | Device |
| 2023 | Failure to Read Input Signal | 12 | Device |
| 2023 | Failure to Capture | 23 | Device |
| 2023 | Device Sensing Problem | 2 | Device |
| 2023 | Device Alarm System | 1 | Device |
| 2023 | Defective Device | 10 | Device |
| 2023 | Data Problem | 3 | Device |
| 2023 | Battery Problem | 16 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 51 | Device |
| 2022 | Unspecified Infection | 6 | Patient |
| 2022 | Unspecified Heart Problem | 1 | Patient |
| 2022 | Tachycardia | 1 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Swelling/ Edema | 1 | Patient |
| 2022 | Purulent Discharge | 1 | Patient |
| 2022 | Presyncope | 1 | Patient |
| 2022 | Pocket Erosion | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Inflammation | 1 | Patient |
| 2022 | Hematoma | 1 | Patient |
| 2022 | Device Overstimulation of Tissue | 1 | Patient |
| 2022 | Chest Pain | 1 | Patient |
| 2022 | Bradycardia | 2 | Patient |
| 2022 | Asystole | 2 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Under-Sensing | 7 | Device |
| 2022 | Telemetry Discrepancy | 3 | Device |
| 2022 | Signal Artifact/Noise | 19 | Device |
| 2022 | Premature Discharge of Battery | 48 | Device |
| 2022 | Pacing Problem | 15 | Device |
| 2022 | Over-Sensing | 21 | Device |
| 2022 | Off-Label Use | 3 | Device |
| 2022 | Migration | 1 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Low impedance | 5 | Device |
| 2022 | Interrogation Problem | 5 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 14 | Device |
| 2022 | Inappropriate or Unexpected Reset | 1 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2022 | High impedance | 21 | Device |
| 2022 | High Capture Threshold | 7 | Device |
| 2022 | False Positive Result | 2 | Device |
| 2022 | Failure to Read Input Signal | 2 | Device |
| 2022 | Failure to Capture | 12 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Device Sensing Problem | 2 | Device |
| 2022 | Device Contaminated at the User Facility | 1 | Device |
| 2022 | Defective Device | 9 | Device |
| 2022 | Data Problem | 3 | Device |
| 2022 | Contamination /Decontamination Problem | 1 | Device |
| 2022 | Contamination | 1 | Device |
| 2022 | Connection Problem | 3 | Device |
| 2022 | Communication or Transmission Problem | 1 | Device |
| 2022 | Battery Problem | 29 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 59 | Device |
| 2021 | Unspecified Infection | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Pneumothorax | 1 | Patient |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Under-Sensing | 2 | Device |
| 2021 | Signal Artifact/Noise | 11 | Device |
| 2021 | Premature Discharge of Battery | 4 | Device |
| 2021 | Pacing Problem | 6 | Device |
| 2021 | Over-Sensing | 12 | Device |
| 2021 | Material Integrity Problem | 1 | Device |
| 2021 | Low impedance | 2 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | High impedance | 8 | Device |
| 2021 | High Capture Threshold | 4 | Device |
| 2021 | Failure to Read Input Signal | 2 | Device |
| 2021 | Failure to Capture | 2 | Device |
| 2021 | Battery Problem | 3 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Under-Sensing | 1 | Device |
| 2020 | Over-Sensing | 2 | Device |
| 2020 | High impedance | 2 | Device |
| 2020 | High Capture Threshold | 1 | Device |
| 2020 | False Positive Result | 1 | Device |
| 2020 | Failure to Read Input Signal | 1 | Device |