PACER LEAD
This device is manufactured by BIOTRONIK AG, BIOTRONIK SE & CO KG, BIOTRONIK SE AND CO KG, UNKNOWN.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 3 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Unstable Capture Threshold | 1 | Device |
| 2024 | Over-Sensing | 1 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Impedance Problem | 2 | Device |
| 2024 | High Capture Threshold | 1 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Ambient Noise Problem | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Low impedance | 1 | Device |
| 2023 | Device Damaged by Another Device | 1 | Device |
| 2023 | Ambient Noise Problem | 1 | Device |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Failure of Implant | 1 | Patient |
| 2022 | Dyspnea | 1 | Patient |
| 2022 | Under-Sensing | 2 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Over-Sensing | 2 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | High Sensing Threshold | 1 | Device |
| 2022 | High Capture Threshold | 2 | Device |
| 2022 | Fracture | 2 | Device |
| 2022 | Failure to Capture | 2 | Device |
| 2022 | Device Dislodged or Dislocated | 5 | Device |
| 2022 | Defective Component | 2 | Device |
| 2022 | Ambient Noise Problem | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | Unspecified Infection | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Insufficient Information | 7 | Patient |
| 2021 | Signal Artifact/Noise | 2 | Device |
| 2021 | Over-Sensing | 4 | Device |
| 2021 | Low impedance | 1 | Device |
| 2021 | Insufficient Information | 2 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | High Capture Threshold | 1 | Device |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Discomfort | 1 | Patient |
| 2020 | Arrhythmia | 1 | Patient |
| 2020 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2020 | Over-Sensing | 1 | Device |
| 2020 | Device Sensing Problem | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Insufficient Information | 1 | Patient |
| 2019 | Under-Sensing | 2 | Device |
| 2019 | Over-Sensing | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2019 | High impedance | 2 | Device |
| 2019 | High Capture Threshold | 1 | Device |
| 2019 | Fracture | 1 | Device |
| 2019 | Failure to Capture | 3 | Device |
| 2019 | Difficult to Remove | 1 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 12 | Device |
| 2019 | Break | 1 | Device |
| 2019 | Ambient Noise Problem | 8 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2018 | Unspecified Infection | 1 | Patient |
| 2018 | Pocket Erosion | 1 | Patient |
| 2018 | Insufficient Information | 1 | Patient |
| 2018 | Under-Sensing | 5 | Device |
| 2018 | Over-Sensing | 3 | Device |
| 2018 | No Pacing | 1 | Device |
| 2018 | Naturally Worn | 1 | Device |
| 2018 | Low impedance | 1 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2018 | High impedance | 8 | Device |
| 2018 | High Capture Threshold | 5 | Device |
| 2018 | Fracture | 4 | Device |
| 2018 | Failure to Sense | 5 | Device |
| 2018 | Failure to Capture | 19 | Device |
| 2018 | Energy Output Problem | 1 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 9 | Device |
| 2018 | Device Abrasion From Instrument Or Another Object | 1 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Ambient Noise Problem | 13 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2017 | Unspecified Infection | 1 | Patient |
| 2017 | Insufficient Information | 2 | Patient |
| 2017 | Unstable Capture Threshold | 1 | Device |
| 2017 | Under-Sensing | 2 | Device |
| 2017 | Sensing Intermittently | 1 | Device |
| 2017 | Pacing Problem | 2 | Device |
| 2017 | Pacing Inadequately | 1 | Device |
| 2017 | Over-Sensing | 7 | Device |
| 2017 | Intermittent Capture | 2 | Device |
| 2017 | Impedance Problem | 2 | Device |
| 2017 | High impedance | 2 | Device |
| 2017 | High Sensing Threshold | 1 | Device |
| 2017 | High Capture Threshold | 3 | Device |
| 2017 | Fracture | 6 | Device |
| 2017 | Failure to Sense | 5 | Device |
| 2017 | Failure to Capture | 11 | Device |
| 2017 | Disconnection | 1 | Device |
| 2017 | Device Sensing Problem | 7 | Device |
| 2017 | Device Dislodged or Dislocated | 15 | Device |
| 2017 | Device Abrasion From Instrument Or Another Object | 2 | Device |
| 2017 | Break | 3 | Device |
| 2017 | Ambient Noise Problem | 9 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2016 | Under-Sensing | 4 | Device |
| 2016 | Pacing Problem | 1 | Device |
| 2016 | Over-Sensing | 2 | Device |
| 2016 | Low impedance | 1 | Device |
| 2016 | Insufficient Information | 2 | Device |
| 2016 | High impedance | 4 | Device |
| 2016 | High Capture Threshold | 2 | Device |
| 2016 | Fracture | 4 | Device |
| 2016 | Failure to Sense | 1 | Device |
| 2016 | Failure to Capture | 8 | Device |
| 2016 | Device Dislodged or Dislocated | 5 | Device |
| 2016 | Device Abrasion From Instrument Or Another Object | 1 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Ambient Noise Problem | 5 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2015 | Under-Sensing | 1 | Device |
| 2015 | Torn Material | 1 | Device |
| 2015 | Over-Sensing | 2 | Device |
| 2015 | Malposition of Device | 1 | Device |
| 2015 | Insufficient Information | 1 | Device |
| 2015 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2015 | Fracture | 1 | Device |
| 2015 | Failure to Capture | 3 | Device |
| 2015 | Device Dislodged or Dislocated | 5 | Device |
| 2015 | Bent | 1 | Device |
| 2015 | Appropriate Term/Code Not Available | 2 | Device |
| 2015 | Ambient Noise Problem | 2 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Under-Sensing | 3 | Device |
| 2014 | Over-Sensing | 1 | Device |
| 2014 | Malposition of Device | 1 | Device |
| 2014 | Intermittent Capture | 1 | Device |
| 2014 | Insufficient Information | 5 | Device |
| 2014 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2014 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2014 | High impedance | 1 | Device |
| 2014 | High Capture Threshold | 4 | Device |
| 2014 | Fracture | 3 | Device |
| 2014 | Failure to Sense | 4 | Device |
| 2014 | Failure to Capture | 13 | Device |
| 2014 | Difficult to Advance | 1 | Device |
| 2014 | Device Sensing Problem | 1 | Device |
| 2014 | Device Dislodged or Dislocated | 27 | Device |
| 2014 | Device Damaged by Another Device | 1 | Device |
| 2014 | Break | 1 | Device |
| 2014 | Ambient Noise Problem | 6 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2013 | Unspecified Infection | 1 | Patient |
| 2013 | Insufficient Information | 2 | Patient |
| 2013 | Insufficient Information | 1 | Device |
| 2013 | High impedance | 1 | Device |
| 2013 | Failure to Capture | 1 | Device |
| 2013 | Device Dislodged or Dislocated | 8 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2012 | Insufficient Information | 1 | Device |
| 2012 | Device Dislodged or Dislocated | 1 | Device |
| 2011 | Insufficient Information | 1 | Patient |
| 2011 | Insufficient Information | 2 | Device |
| 2011 | Incomplete or Inadequate Connection | 1 | Device |
| 2011 | Device Dislodged or Dislocated | 1 | Device |
| 2010 | Loose or Intermittent Connection | 1 | Device |
| 2010 | High Capture Threshold | 1 | Device |
| 2010 | Device Dislodged or Dislocated | 1 | Device |