IMPLANTABLE TACHY LEAD
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 5 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Shock from Patient Lead(s) | 8 | Patient |
| 2024 | Obstruction/Occlusion | 3 | Patient |
| 2024 | Insufficient Information | 3 | Patient |
| 2024 | Failure of Implant | 1 | Patient |
| 2024 | Erythema | 1 | Patient |
| 2024 | Erosion | 3 | Patient |
| 2024 | Dizziness | 3 | Patient |
| 2024 | Discomfort | 3 | Patient |
| 2024 | Bradycardia | 1 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Unstable Capture Threshold | 1 | Device |
| 2024 | Under-Sensing | 5 | Device |
| 2024 | Signal Artifact/Noise | 23 | Device |
| 2024 | Pacing Problem | 2 | Device |
| 2024 | Over-Sensing | 32 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Intermittent Capture | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
| 2024 | Impedance Problem | 25 | Device |
| 2024 | High impedance | 42 | Device |
| 2024 | High Capture Threshold | 14 | Device |
| 2024 | Fracture | 23 | Device |
| 2024 | Failure to Capture | 2 | Device |
| 2024 | Device Dislodged or Dislocated | 3 | Device |
| 2024 | Decreased Sensitivity | 3 | Device |
| 2024 | Capturing Problem | 3 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 5 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2023 | Ventricular Fibrillation | 1 | Patient |
| 2023 | Unspecified Infection | 12 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Stroke/CVA | 2 | Patient |
| 2023 | Shock from Patient Lead(s) | 10 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Pulmonary Edema | 1 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Obstruction/Occlusion | 1 | Patient |
| 2023 | Non specific EKG/ECG Changes | 1 | Patient |
| 2023 | Loss of consciousness | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2023 | Great Vessel Perforation | 1 | Patient |
| 2023 | Fall | 2 | Patient |
| 2023 | Erosion | 3 | Patient |
| 2023 | Emotional Changes | 1 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Dizziness | 2 | Patient |
| 2023 | Chest Pain | 2 | Patient |
| 2023 | Cardiac Perforation | 2 | Patient |
| 2023 | Bradycardia | 2 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Anxiety | 2 | Patient |
| 2023 | Unstable Capture Threshold | 3 | Device |
| 2023 | Under-Sensing | 8 | Device |
| 2023 | Thermal Decomposition of Device | 1 | Device |
| 2023 | Signal Artifact/Noise | 23 | Device |
| 2023 | Pacing Problem | 5 | Device |
| 2023 | Over-Sensing | 36 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | Noise, Audible | 2 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 12 | Device |
| 2023 | Impedance Problem | 18 | Device |
| 2023 | High impedance | 27 | Device |
| 2023 | High Sensing Threshold | 1 | Device |
| 2023 | High Capture Threshold | 7 | Device |
| 2023 | Fracture | 31 | Device |
| 2023 | Failure to Capture | 4 | Device |
| 2023 | Electromagnetic Interference | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Decreased Sensitivity | 7 | Device |
| 2023 | Capturing Problem | 4 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Appropriate Term/Code Not Available | 7 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2022 | Tachycardia | 1 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Shock from Patient Lead(s) | 3 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Failure of Implant | 2 | Patient |
| 2022 | Unstable Capture Threshold | 2 | Device |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Signal Artifact/Noise | 29 | Device |
| 2022 | Pacing Problem | 2 | Device |
| 2022 | Over-Sensing | 30 | Device |
| 2022 | Nonstandard Device | 6 | Device |
| 2022 | Low impedance | 3 | Device |
| 2022 | Intermittent Capture | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 9 | Device |
| 2022 | Impedance Problem | 19 | Device |
| 2022 | High impedance | 32 | Device |
| 2022 | High Capture Threshold | 13 | Device |
| 2022 | Fracture | 29 | Device |
| 2022 | Failure to Capture | 2 | Device |
| 2022 | Device-Device Incompatibility | 1 | Device |
| 2022 | Defective Device | 2 | Device |
| 2022 | Defective Component | 3 | Device |
| 2022 | Decreased Sensitivity | 2 | Device |
| 2022 | Capturing Problem | 8 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 5 | Device |
| 2022 | Ambient Noise Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Insufficient Information | 17 | Patient |
| 2021 | Under-Sensing | 2 | Device |
| 2021 | Signal Artifact/Noise | 4 | Device |
| 2021 | Over-Sensing | 2 | Device |
| 2021 | Output Problem | 1 | Device |
| 2021 | Nonstandard Device | 4 | Device |
| 2021 | No Pacing | 2 | Device |
| 2021 | Insufficient Information | 6 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2021 | Impedance Problem | 3 | Device |
| 2021 | High impedance | 12 | Device |
| 2021 | High Capture Threshold | 4 | Device |
| 2021 | Fracture | 2 | Device |
| 2021 | Decreased Sensitivity | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Unspecified Infection | 2 | Patient |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Cardiac Perforation | 1 | Patient |
| 2020 | Signal Artifact/Noise | 3 | Device |
| 2020 | Pacing Problem | 1 | Device |
| 2020 | Over-Sensing | 2 | Device |
| 2020 | Nonstandard Device | 1 | Device |
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2020 | Impedance Problem | 2 | Device |
| 2020 | High impedance | 2 | Device |
| 2020 | High Capture Threshold | 1 | Device |
| 2020 | Fracture | 2 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 3 | Device |