IMPLANTABLE TACHY LEAD
This device is manufactured by MEDTRONIC, MEDTRONIC EP SYSTEMS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 2 | Patient |
| 2024 | Shock from Patient Lead(s) | 1 | Patient |
| 2024 | Obstruction/Occlusion | 1 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Failure of Implant | 3 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2024 | Bacteremia | 1 | Patient |
| 2024 | Under-Sensing | 1 | Device |
| 2024 | Signal Artifact/Noise | 1 | Device |
| 2024 | Over-Sensing | 7 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2024 | Impedance Problem | 5 | Device |
| 2024 | High impedance | 6 | Device |
| 2024 | High Capture Threshold | 3 | Device |
| 2024 | Fracture | 4 | Device |
| 2024 | Failure to Capture | 1 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Twitching | 1 | Patient |
| 2023 | Skin Infection | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 3 | Patient |
| 2023 | Respiratory Failure | 1 | Patient |
| 2023 | Pneumothorax | 1 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Fluid Discharge | 2 | Patient |
| 2023 | Erythema | 1 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Cellulitis | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Ambulation Difficulties | 1 | Patient |
| 2023 | Under-Sensing | 1 | Device |
| 2023 | Signal Artifact/Noise | 7 | Device |
| 2023 | Over-Sensing | 12 | Device |
| 2023 | Low impedance | 2 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | High impedance | 10 | Device |
| 2023 | High Capture Threshold | 5 | Device |
| 2023 | Fracture | 8 | Device |
| 2023 | Device-Device Incompatibility | 1 | Device |
| 2023 | Device Sensing Problem | 1 | Device |
| 2023 | Decreased Sensitivity | 1 | Device |
| 2023 | Capturing Problem | 1 | Device |
| 2023 | Break | 3 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Failure of Implant | 3 | Patient |
| 2022 | Endocarditis | 1 | Patient |
| 2022 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2022 | Chest Pain | 1 | Patient |
| 2022 | Bacteremia | 1 | Patient |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Signal Artifact/Noise | 7 | Device |
| 2022 | Retraction Problem | 1 | Device |
| 2022 | Physical Resistance/Sticking | 1 | Device |
| 2022 | Over-Sensing | 7 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2022 | Impedance Problem | 4 | Device |
| 2022 | High impedance | 12 | Device |
| 2022 | High Sensing Threshold | 1 | Device |
| 2022 | High Capture Threshold | 3 | Device |
| 2022 | Fracture | 6 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Difficult or Delayed Separation | 1 | Device |
| 2022 | Defective Device | 2 | Device |
| 2022 | Defective Component | 3 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2021 | Stenosis | 1 | Patient |
| 2021 | Insufficient Information | 15 | Patient |
| 2021 | Unexpected Therapeutic Results | 1 | Device |
| 2021 | Signal Artifact/Noise | 2 | Device |
| 2021 | Pacing Problem | 2 | Device |
| 2021 | Over-Sensing | 3 | Device |
| 2021 | Low impedance | 2 | Device |
| 2021 | Insufficient Information | 2 | Device |
| 2021 | Impedance Problem | 6 | Device |
| 2021 | High impedance | 3 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Unspecified Infection | 1 | Patient |
| 2020 | Insufficient Information | 2 | Patient |
| 2020 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2020 | Product Quality Problem | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |