ICD LEAD
This device is manufactured by BIOTRONIK SE & CO KG.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Ventricular Fibrillation | 1 | Patient |
| 2024 | Unspecified Infection | 12 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Shock from Patient Lead(s) | 15 | Patient |
| 2024 | Septic Shock | 1 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Cardiogenic Shock | 1 | Patient |
| 2024 | Under-Sensing | 2 | Device |
| 2024 | Pacing Intermittently | 1 | Device |
| 2024 | Over-Sensing | 19 | Device |
| 2024 | Low impedance | 4 | Device |
| 2024 | Intermittent Capture | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 12 | Device |
| 2024 | Impedance Problem | 1 | Device |
| 2024 | High impedance | 7 | Device |
| 2024 | High Capture Threshold | 3 | Device |
| 2024 | Fracture | 7 | Device |
| 2024 | Failure to Convert Rhythm | 1 | Device |
| 2024 | Failure to Capture | 2 | Device |
| 2024 | Device Sensing Problem | 3 | Device |
| 2024 | Device Dislodged or Dislocated | 7 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Ambient Noise Problem | 11 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2023 | Unspecified Infection | 13 | Patient |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Twiddlers Syndrome | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 15 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Foreign Body In Patient | 1 | Patient |
| 2023 | Endocarditis | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cardiac Perforation | 4 | Patient |
| 2023 | Unstable Capture Threshold | 1 | Device |
| 2023 | Signal Artifact/Noise | 3 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Over-Sensing | 20 | Device |
| 2023 | Low impedance | 3 | Device |
| 2023 | Loss of Threshold | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 14 | Device |
| 2023 | Impedance Problem | 4 | Device |
| 2023 | High impedance | 6 | Device |
| 2023 | High Capture Threshold | 3 | Device |
| 2023 | Fracture | 11 | Device |
| 2023 | Failure to Capture | 3 | Device |
| 2023 | Device Sensing Problem | 3 | Device |
| 2023 | Device Dislodged or Dislocated | 5 | Device |
| 2023 | Capturing Problem | 1 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Ambient Noise Problem | 28 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Shock from Patient Lead(s) | 1 | Patient |
| 2022 | Unstable Capture Threshold | 1 | Device |
| 2022 | Signal Artifact/Noise | 1 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Over-Sensing | 33 | Device |
| 2022 | Low impedance | 2 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 19 | Device |
| 2022 | Impedance Problem | 4 | Device |
| 2022 | High impedance | 5 | Device |
| 2022 | High Capture Threshold | 2 | Device |
| 2022 | Fracture | 4 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Device Sensing Problem | 5 | Device |
| 2022 | Device Dislodged or Dislocated | 8 | Device |
| 2022 | Break | 5 | Device |
| 2022 | Ambient Noise Problem | 14 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Over-Sensing | 2 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | Break | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Unspecified Infection | 1 | Patient |
| 2019 | Sepsis | 1 | Patient |
| 2019 | Bacterial Infection | 1 | Patient |
| 2019 | Unstable Capture Threshold | 1 | Device |
| 2019 | Under-Sensing | 6 | Device |
| 2019 | Signal Artifact/Noise | 2 | Device |
| 2019 | Retraction Problem | 1 | Device |
| 2019 | Over-Sensing | 17 | Device |
| 2019 | Mechanical Problem | 4 | Device |
| 2019 | Low impedance | 3 | Device |
| 2019 | Insufficient Information | 2 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 14 | Device |
| 2019 | Impedance Problem | 1 | Device |
| 2019 | High impedance | 8 | Device |
| 2019 | High Capture Threshold | 7 | Device |
| 2019 | Failure to Capture | 9 | Device |
| 2019 | Device Sensing Problem | 2 | Device |
| 2019 | Device Dislodged or Dislocated | 33 | Device |
| 2019 | Break | 6 | Device |
| 2019 | Ambient Noise Problem | 14 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 40 | Device |
| 2018 | Under-Sensing | 4 | Device |
| 2018 | Signal Artifact/Noise | 1 | Device |
| 2018 | Positioning Failure | 1 | Device |
| 2018 | Over-Sensing | 15 | Device |
| 2018 | Mechanical Problem | 2 | Device |
| 2018 | Material Discolored | 1 | Device |
| 2018 | Low impedance | 3 | Device |
| 2018 | Loose or Intermittent Connection | 1 | Device |
| 2018 | Intermittent Shock/Stimulation | 1 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 10 | Device |
| 2018 | Impedance Problem | 3 | Device |
| 2018 | High impedance | 4 | Device |
| 2018 | High Capture Threshold | 8 | Device |
| 2018 | Fracture | 1 | Device |
| 2018 | Failure to Sense | 1 | Device |
| 2018 | Failure to Capture | 5 | Device |
| 2018 | Device Sensing Problem | 6 | Device |
| 2018 | Device Dislodged or Dislocated | 30 | Device |
| 2018 | Defibrillation/Stimulation Problem | 1 | Device |
| 2018 | Defective Component | 1 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Ambient Noise Problem | 6 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 52 | Device |
| 2017 | Unstable Capture Threshold | 1 | Device |
| 2017 | Signal Artifact/Noise | 1 | Device |
| 2017 | Over-Sensing | 2 | Device |
| 2017 | Intermittent Capture | 2 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2017 | Impedance Problem | 1 | Device |
| 2017 | High impedance | 4 | Device |
| 2017 | High Capture Threshold | 8 | Device |
| 2017 | Failure to Capture | 2 | Device |
| 2017 | Device Sensing Problem | 4 | Device |
| 2017 | Device Dislodged or Dislocated | 21 | Device |
| 2017 | Defective Component | 2 | Device |
| 2017 | Battery Problem | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 22 | Device |