ICD LEAD
This device is manufactured by BIOTRONIK SE & CO KG, BIOTRONIK SE AND CO KG.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Shock from Patient Lead(s) | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Failure of Implant | 1 | Patient |
| 2024 | Low impedance | 1 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | High Capture Threshold | 1 | Device |
| 2024 | Fracture | 2 | Device |
| 2024 | Ambient Noise Problem | 3 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 1 | Patient |
| 2023 | Over-Sensing | 1 | Device |
| 2023 | Noise, Audible | 2 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | High impedance | 2 | Device |
| 2023 | Fracture | 3 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 1 | Device |
| 2023 | Ambient Noise Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Tachycardia | 1 | Patient |
| 2022 | Electric Shock | 1 | Patient |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Over-Sensing | 2 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2022 | Impedance Problem | 2 | Device |
| 2022 | High impedance | 2 | Device |
| 2022 | Fracture | 2 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Ambient Noise Problem | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Impedance Problem | 1 | Device |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Shock from Patient Lead(s) | 1 | Patient |
| 2019 | Insufficient Information | 2 | Patient |
| 2019 | Signal Artifact/Noise | 2 | Device |
| 2019 | Pacing Inadequately | 1 | Device |
| 2019 | Over-Sensing | 9 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 14 | Device |
| 2019 | Impedance Problem | 1 | Device |
| 2019 | High impedance | 5 | Device |
| 2019 | High Capture Threshold | 1 | Device |
| 2019 | Fracture | 5 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Device Sensing Problem | 2 | Device |
| 2019 | Break | 3 | Device |
| 2019 | Ambient Noise Problem | 19 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2018 | Pain | 1 | Patient |
| 2018 | Insufficient Information | 3 | Patient |
| 2018 | Asystole | 1 | Patient |
| 2018 | Unstable Capture Threshold | 1 | Device |
| 2018 | Under-Sensing | 2 | Device |
| 2018 | Therapeutic or Diagnostic Output Failure | 2 | Device |
| 2018 | Signal Artifact/Noise | 2 | Device |
| 2018 | Pacing Intermittently | 1 | Device |
| 2018 | Over-Sensing | 11 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 9 | Device |
| 2018 | Impedance Problem | 2 | Device |
| 2018 | High impedance | 11 | Device |
| 2018 | High Capture Threshold | 2 | Device |
| 2018 | Fracture | 10 | Device |
| 2018 | Failure to Disconnect | 1 | Device |
| 2018 | Failure to Capture | 2 | Device |
| 2018 | Device Sensing Problem | 4 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Ambient Noise Problem | 19 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2017 | Shock from Patient Lead(s) | 1 | Patient |
| 2017 | Insufficient Information | 1 | Patient |
| 2017 | Under-Sensing | 1 | Device |
| 2017 | Signal Artifact/Noise | 2 | Device |
| 2017 | Over-Sensing | 10 | Device |
| 2017 | Low impedance | 3 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 15 | Device |
| 2017 | Impedance Problem | 1 | Device |
| 2017 | High impedance | 12 | Device |
| 2017 | High Capture Threshold | 2 | Device |
| 2017 | Fracture | 12 | Device |
| 2017 | Failure to Capture | 3 | Device |
| 2017 | Device Abrasion From Instrument Or Another Object | 3 | Device |
| 2017 | Defibrillation/Stimulation Problem | 1 | Device |
| 2017 | Break | 3 | Device |
| 2017 | Ambient Noise Problem | 18 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2016 | Under-Sensing | 1 | Device |
| 2016 | Pacing Problem | 1 | Device |
| 2016 | Over-Sensing | 7 | Device |
| 2016 | Low impedance | 1 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 10 | Device |
| 2016 | Impedance Problem | 4 | Device |
| 2016 | High impedance | 9 | Device |
| 2016 | High Capture Threshold | 1 | Device |
| 2016 | Fracture | 9 | Device |
| 2016 | Failure to Capture | 3 | Device |
| 2016 | Device Dislodged or Dislocated | 1 | Device |
| 2016 | Break | 2 | Device |
| 2016 | Ambient Noise Problem | 12 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2015 | High Capture Threshold | 1 | Device |
| 2015 | Failure to Capture | 1 | Device |
| 2015 | Break | 1 | Device |
| 2015 | Appropriate Term/Code Not Available | 1 | Device |
| 2015 | Ambient Noise Problem | 4 | Device |
| 2014 | Chest Pain | 1 | Patient |
| 2014 | Stretched | 1 | Device |
| 2014 | Over-Sensing | 5 | Device |
| 2014 | Intermittent Capture | 1 | Device |
| 2014 | Insufficient Information | 1 | Device |
| 2014 | Inappropriate/Inadequate Shock/Stimulation | 12 | Device |
| 2014 | Impedance Problem | 2 | Device |
| 2014 | High impedance | 11 | Device |
| 2014 | High Capture Threshold | 5 | Device |
| 2014 | Fracture | 5 | Device |
| 2014 | Failure to Interrogate | 1 | Device |
| 2014 | Device Sensing Problem | 1 | Device |
| 2014 | Device Dislodged or Dislocated | 1 | Device |
| 2014 | Device Abrasion From Instrument Or Another Object | 1 | Device |
| 2014 | Defibrillation/Stimulation Problem | 1 | Device |
| 2014 | Break | 3 | Device |
| 2014 | Ambient Noise Problem | 24 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2013 | Under-Sensing | 1 | Device |
| 2013 | Over-Sensing | 1 | Device |
| 2013 | Low impedance | 2 | Device |
| 2013 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2013 | High impedance | 1 | Device |
| 2013 | Fracture | 2 | Device |
| 2013 | Failure to Convert Rhythm | 1 | Device |
| 2013 | Failure to Capture | 1 | Device |
| 2013 | Device Dislodged or Dislocated | 1 | Device |
| 2013 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Ambient Noise Problem | 4 | Device |
| 2012 | Insufficient Information | 2 | Patient |
| 2012 | Signal Artifact/Noise | 1 | Device |
| 2012 | High impedance | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Insufficient Information | 2 | Patient |
| 2011 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2011 | Product Quality Problem | 1 | Device |
| 2011 | Insufficient Information | 1 | Device |
| 2011 | Failure to Capture | 1 | Device |
| 2011 | Difficult to Remove | 1 | Device |
| 2010 | High Capture Threshold | 1 | Device |