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 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2024 | High impedance | 1 | Device |
| 2024 | Ambient Noise Problem | 1 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 1 | Patient |
| 2023 | Foreign Body In Patient | 1 | Patient |
| 2023 | Over-Sensing | 1 | Device |
| 2023 | No Pacing | 1 | Device |
| 2023 | Low impedance | 2 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | High impedance | 2 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Ambient Noise Problem | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Shock from Patient Lead(s) | 1 | Patient |
| 2022 | Over-Sensing | 3 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2022 | Impedance Problem | 1 | Device |
| 2022 | High Sensing Threshold | 1 | Device |
| 2022 | Fracture | 3 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Ambient Noise Problem | 8 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Insufficient Information | 4 | Patient |
| 2021 | Over-Sensing | 1 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | Fracture | 2 | Device |
| 2021 | Display or Visual Feedback Problem | 1 | Device |
| 2019 | Insufficient Information | 1 | Patient |
| 2019 | Foreign Body In Patient | 1 | Patient |
| 2019 | Under-Sensing | 2 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2019 | Over-Sensing | 10 | Device |
| 2019 | Naturally Worn | 1 | Device |
| 2019 | Low impedance | 1 | Device |
| 2019 | Interrogation Problem | 1 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 17 | Device |
| 2019 | Impedance Problem | 2 | Device |
| 2019 | High impedance | 8 | Device |
| 2019 | High Capture Threshold | 1 | Device |
| 2019 | Fracture | 7 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 1 | Device |
| 2019 | Break | 2 | Device |
| 2019 | Ambient Noise Problem | 14 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2018 | Signal Artifact/Noise | 1 | Device |
| 2018 | Over-Sensing | 15 | Device |
| 2018 | Naturally Worn | 1 | Device |
| 2018 | Intermittent Capture | 2 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 17 | Device |
| 2018 | Impedance Problem | 2 | Device |
| 2018 | High impedance | 9 | Device |
| 2018 | High Capture Threshold | 2 | Device |
| 2018 | Fracture | 7 | Device |
| 2018 | Failure to Capture | 2 | Device |
| 2018 | Break | 3 | Device |
| 2018 | Arcing of Electrodes | 1 | Device |
| 2018 | Ambient Noise Problem | 20 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2017 | Under-Sensing | 1 | Device |
| 2017 | Premature Elective Replacement Indicator | 1 | Device |
| 2017 | Pacing Problem | 1 | Device |
| 2017 | Over-Sensing | 22 | Device |
| 2017 | No Pacing | 2 | Device |
| 2017 | Material Separation | 1 | Device |
| 2017 | Low impedance | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 25 | Device |
| 2017 | Impedance Problem | 3 | Device |
| 2017 | High impedance | 16 | Device |
| 2017 | High Capture Threshold | 3 | Device |
| 2017 | Fracture | 12 | Device |
| 2017 | Failure to Capture | 4 | Device |
| 2017 | Device Sensing Problem | 1 | Device |
| 2017 | Device Damaged by Another Device | 1 | Device |
| 2017 | Device Abrasion From Instrument Or Another Object | 4 | Device |
| 2017 | Defibrillation/Stimulation Problem | 1 | Device |
| 2017 | Ambient Noise Problem | 30 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2016 | Under-Sensing | 1 | Device |
| 2016 | Over-Sensing | 9 | Device |
| 2016 | Low impedance | 2 | Device |
| 2016 | Insufficient Information | 2 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
| 2016 | Impedance Problem | 1 | Device |
| 2016 | High impedance | 9 | Device |
| 2016 | High Capture Threshold | 2 | Device |
| 2016 | Fracture | 4 | Device |
| 2016 | Failure to Capture | 2 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Break | 4 | Device |
| 2016 | Ambient Noise Problem | 12 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Over-Sensing | 2 | Device |
| 2015 | Insufficient Information | 1 | Device |
| 2015 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2015 | Impedance Problem | 1 | Device |
| 2015 | High impedance | 2 | Device |
| 2015 | Fracture | 2 | Device |
| 2015 | Failure to Capture | 1 | Device |
| 2015 | Device Dislodged or Dislocated | 1 | Device |
| 2015 | Break | 2 | Device |
| 2015 | Ambient Noise Problem | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Tachycardia | 1 | Patient |
| 2014 | Signal Artifact/Noise | 3 | Device |
| 2014 | Over-Sensing | 8 | Device |
| 2014 | Noise, Audible | 1 | Device |
| 2014 | Naturally Worn | 1 | Device |
| 2014 | Malposition of Device | 1 | Device |
| 2014 | Low impedance | 3 | Device |
| 2014 | Loose or Intermittent Connection | 1 | Device |
| 2014 | Kinked | 1 | Device |
| 2014 | Insufficient Information | 1 | Device |
| 2014 | Inappropriate/Inadequate Shock/Stimulation | 20 | Device |
| 2014 | Impedance Problem | 2 | Device |
| 2014 | High impedance | 7 | Device |
| 2014 | High Capture Threshold | 2 | Device |
| 2014 | Fracture | 3 | Device |
| 2014 | Failure to Capture | 2 | Device |
| 2014 | Electromagnetic Interference | 1 | Device |
| 2014 | Device Sensing Problem | 3 | Device |
| 2014 | Device Dislodged or Dislocated | 1 | Device |
| 2014 | Break | 6 | Device |
| 2014 | Ambient Noise Problem | 18 | Device |
| 2013 | Insufficient Information | 1 | Patient |
| 2013 | Signal Artifact/Noise | 1 | Device |
| 2013 | Over-Sensing | 4 | Device |
| 2013 | Naturally Worn | 1 | Device |
| 2013 | Loose or Intermittent Connection | 1 | Device |
| 2013 | Insufficient Information | 1 | Device |
| 2013 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2013 | Fracture | 2 | Device |
| 2013 | Break | 1 | Device |
| 2013 | Ambient Noise Problem | 3 | Device |
| 2012 | Unspecified Infection | 1 | Patient |
| 2012 | Insufficient Information | 1 | Patient |
| 2012 | Over-Sensing | 1 | Device |
| 2012 | High impedance | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Unspecified Infection | 1 | Patient |
| 2011 | Insufficient Information | 1 | Patient |
| 2011 | Impedance Problem | 1 | Device |
| 2011 | High impedance | 1 | Device |
| 2011 | High Capture Threshold | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2010 | Insufficient Information | 1 | Device |
| 2010 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2010 | Ambient Noise Problem | 2 | Device |