IMPLANTABLE LEAD
This device is manufactured by BOSTON SCIENTIFIC CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 3 | Patient |
| 2024 | Vomiting | 1 | Patient |
| 2024 | Ventricular Fibrillation | 2 | Patient |
| 2024 | Unspecified Infection | 78 | Patient |
| 2024 | Unspecified Heart Problem | 1 | Patient |
| 2024 | Twiddlers Syndrome | 1 | Patient |
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Syncope/Fainting | 2 | Patient |
| 2024 | Shock from Patient Lead(s) | 15 | Patient |
| 2024 | Sepsis | 4 | Patient |
| 2024 | Pericardial Effusion | 1 | Patient |
| 2024 | Perforation | 1 | Patient |
| 2024 | Obstruction/Occlusion | 1 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Multiple Organ Dysfunction Syndrome | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Impaired Healing | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Foreign Body In Patient | 2 | Patient |
| 2024 | Fluid Discharge | 2 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Failure of Implant | 1 | Patient |
| 2024 | Electric Shock | 2 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Diarrhea | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 2 | Patient |
| 2024 | Cough | 1 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Calcium Deposits/Calcification | 4 | Patient |
| 2024 | Bradycardia | 7 | Patient |
| 2024 | Bacterial Infection | 5 | Patient |
| 2024 | Asystole | 3 | Patient |
| 2024 | Arrhythmia | 2 | Patient |
| 2024 | Anxiety | 1 | Patient |
| 2024 | Use of Device Problem | 1 | Device |
| 2024 | Unexpected Therapeutic Results | 2 | Device |
| 2024 | Under-Sensing | 2 | Device |
| 2024 | Signal Artifact/Noise | 38 | Device |
| 2024 | Pacing Problem | 18 | Device |
| 2024 | Over-Sensing | 34 | Device |
| 2024 | No Apparent Adverse Event | 5 | Device |
| 2024 | Migration | 1 | Device |
| 2024 | Material Integrity Problem | 2 | Device |
| 2024 | Low impedance | 8 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
| 2024 | Impedance Problem | 10 | Device |
| 2024 | High impedance | 157 | Device |
| 2024 | High Capture Threshold | 28 | Device |
| 2024 | Fracture | 27 | Device |
| 2024 | Failure to Read Input Signal | 6 | Device |
| 2024 | Failure to Convert Rhythm | 6 | Device |
| 2024 | Failure to Capture | 15 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Device Sensing Problem | 3 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Defective Device | 16 | Device |
| 2024 | Connection Problem | 6 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 73 | Device |
| 2023 | Wound Dehiscence | 2 | Patient |
| 2023 | Ventricular Fibrillation | 2 | Patient |
| 2023 | Unspecified Infection | 79 | Patient |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Twiddlers Syndrome | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 6 | Patient |
| 2023 | Swelling/ Edema | 2 | Patient |
| 2023 | Shock from Patient Lead(s) | 4 | Patient |
| 2023 | Sepsis | 6 | Patient |
| 2023 | Pocket Erosion | 3 | Patient |
| 2023 | Pericardial Effusion | 1 | Patient |
| 2023 | Perforation | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Nerve Damage | 1 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Insufficient Information | 5 | Patient |
| 2023 | Impaired Healing | 1 | Patient |
| 2023 | Hematoma | 2 | Patient |
| 2023 | Foreign Body In Patient | 2 | Patient |
| 2023 | Fluid Discharge | 1 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Fall | 1 | Patient |
| 2023 | Failure of Implant | 1 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Endocarditis | 3 | Patient |
| 2023 | Electric Shock | 29 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Discomfort | 4 | Patient |
| 2023 | Diminished Pulse Pressure | 1 | Patient |
| 2023 | Device Overstimulation of Tissue | 2 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cardiac Tamponade | 1 | Patient |
| 2023 | Cardiac Perforation | 2 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Bradycardia | 2 | Patient |
| 2023 | Bacterial Infection | 7 | Patient |
| 2023 | Atrial Fibrillation | 1 | Patient |
| 2023 | Asystole | 7 | Patient |
| 2023 | Arrhythmia | 2 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Unexpected Therapeutic Results | 2 | Device |
| 2023 | Under-Sensing | 12 | Device |
| 2023 | Signal Artifact/Noise | 63 | Device |
| 2023 | Positioning Problem | 2 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Pacing Problem | 28 | Device |
| 2023 | Over-Sensing | 65 | Device |
| 2023 | Off-Label Use | 1 | Device |
| 2023 | No Apparent Adverse Event | 9 | Device |
| 2023 | Mechanical Problem | 4 | Device |
| 2023 | Material Integrity Problem | 4 | Device |
| 2023 | Malposition of Device | 1 | Device |
| 2023 | Low impedance | 20 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 11 | Device |
| 2023 | Impedance Problem | 11 | Device |
| 2023 | High impedance | 189 | Device |
| 2023 | High Capture Threshold | 48 | Device |
| 2023 | Fracture | 29 | Device |
| 2023 | Failure to Sense | 2 | Device |
| 2023 | Failure to Read Input Signal | 14 | Device |
| 2023 | Failure to Convert Rhythm | 9 | Device |
| 2023 | Failure to Capture | 12 | Device |
| 2023 | Difficult to Remove | 4 | Device |
| 2023 | Device Dislodged or Dislocated | 11 | Device |
| 2023 | Device Contaminated at the User Facility | 1 | Device |
| 2023 | Defibrillation/Stimulation Problem | 3 | Device |
| 2023 | Defective Device | 13 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 85 | Device |
| 2022 | Unspecified Infection | 11 | Patient |
| 2022 | Undesired Nerve Stimulation | 1 | Patient |
| 2022 | Twiddlers Syndrome | 1 | Patient |
| 2022 | Shock from Patient Lead(s) | 3 | Patient |
| 2022 | Pocket Erosion | 4 | Patient |
| 2022 | Electric Shock | 10 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Calcium Deposits/Calcification | 1 | Patient |
| 2022 | Bacterial Infection | 1 | Patient |
| 2022 | Unstable Capture Threshold | 1 | Device |
| 2022 | Unexpected Therapeutic Results | 2 | Device |
| 2022 | Under-Sensing | 3 | Device |
| 2022 | Signal Artifact/Noise | 65 | Device |
| 2022 | Pocket Stimulation | 2 | Device |
| 2022 | Pacing Problem | 31 | Device |
| 2022 | Over-Sensing | 51 | Device |
| 2022 | No Apparent Adverse Event | 13 | Device |
| 2022 | Migration | 1 | Device |
| 2022 | Material Integrity Problem | 6 | Device |
| 2022 | Low impedance | 33 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 25 | Device |
| 2022 | Impedance Problem | 6 | Device |
| 2022 | High impedance | 231 | Device |
| 2022 | High Capture Threshold | 56 | Device |
| 2022 | Fracture | 33 | Device |
| 2022 | Failure to Sense | 1 | Device |
| 2022 | Failure to Read Input Signal | 18 | Device |
| 2022 | Failure to Convert Rhythm | 3 | Device |
| 2022 | Failure to Capture | 18 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 17 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2022 | Defective Device | 20 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 96 | Device |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Electric Shock | 4 | Patient |
| 2021 | Dizziness | 1 | Patient |
| 2021 | Device Overstimulation of Tissue | 1 | Patient |
| 2021 | Cardiac Perforation | 1 | Patient |
| 2021 | Calcium Deposits/Calcification | 1 | Patient |
| 2021 | Asystole | 1 | Patient |
| 2021 | Arrhythmia | 1 | Patient |
| 2021 | Unexpected Therapeutic Results | 1 | Device |
| 2021 | Signal Artifact/Noise | 8 | Device |
| 2021 | Pacing Problem | 7 | Device |
| 2021 | Over-Sensing | 8 | Device |
| 2021 | No Apparent Adverse Event | 2 | Device |
| 2021 | Low impedance | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2021 | High impedance | 51 | Device |
| 2021 | High Capture Threshold | 5 | Device |
| 2021 | Fracture | 2 | Device |
| 2021 | Failure to Read Input Signal | 1 | Device |
| 2021 | Failure to Convert Rhythm | 1 | Device |
| 2021 | Failure to Capture | 2 | Device |
| 2021 | Defective Device | 4 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2020 | Shock from Patient Lead(s) | 1 | Patient |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Electric Shock | 1 | Patient |
| 2020 | Signal Artifact/Noise | 2 | Device |
| 2020 | Pacing Problem | 1 | Device |
| 2020 | Over-Sensing | 2 | Device |
| 2020 | Low impedance | 2 | Device |
| 2020 | High impedance | 15 | Device |
| 2020 | High Capture Threshold | 2 | Device |
| 2020 | Fracture | 1 | Device |
| 2020 | Failure to Read Input Signal | 2 | Device |
| 2020 | Failure to Convert Rhythm | 1 | Device |
| 2020 | Failure to Capture | 1 | Device |
| 2020 | Defective Device | 2 | Device |
| 2020 | Capturing Problem | 1 | Device |