PACING LEAD
This device is manufactured by BIOTRONIK SE & CO KG, ST JUDE MEDICAL, UNKNOWN.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 32 | Patient |
| 2024 | Undesired Nerve Stimulation | 1 | Patient |
| 2024 | Twiddlers Syndrome | 1 | Patient |
| 2024 | Syncope/Fainting | 2 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Foreign Body In Patient | 2 | Patient |
| 2024 | Endocarditis | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Device Embedded In Tissue or Plaque | 2 | Patient |
| 2024 | Cardiac Perforation | 2 | Patient |
| 2024 | Bacteremia | 3 | Patient |
| 2024 | Atrial Flutter | 1 | Patient |
| 2024 | Asystole | 1 | Patient |
| 2024 | Unstable Capture Threshold | 9 | Device |
| 2024 | Pacing Problem | 1 | Device |
| 2024 | Over-Sensing | 7 | Device |
| 2024 | No Pacing | 2 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Intermittent Capture | 1 | Device |
| 2024 | Impedance Problem | 3 | Device |
| 2024 | High impedance | 5 | Device |
| 2024 | High Capture Threshold | 9 | Device |
| 2024 | Fracture | 4 | Device |
| 2024 | Failure to Sense | 1 | Device |
| 2024 | Failure to Capture | 12 | Device |
| 2024 | Device Sensing Problem | 2 | Device |
| 2024 | Device Dislodged or Dislocated | 54 | Device |
| 2024 | Break | 5 | Device |
| 2024 | Ambient Noise Problem | 5 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 32 | Device |
| 2023 | Unspecified Infection | 17 | Patient |
| 2023 | Twiddlers Syndrome | 1 | Patient |
| 2023 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Peripheral Edema | 1 | Patient |
| 2023 | Pericarditis | 1 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Implant Pain | 1 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Foreign Body In Patient | 1 | Patient |
| 2023 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2023 | Cardiac Tamponade | 1 | Patient |
| 2023 | Cardiac Perforation | 3 | Patient |
| 2023 | Bacteremia | 1 | Patient |
| 2023 | Over-Sensing | 1 | Device |
| 2023 | No Pacing | 1 | Device |
| 2023 | Migration or Expulsion of Device | 1 | Device |
| 2023 | Low impedance | 1 | Device |
| 2023 | Loss of Threshold | 1 | Device |
| 2023 | Intermittent Capture | 1 | Device |
| 2023 | Insufficient Information | 2 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | High impedance | 5 | Device |
| 2023 | High Capture Threshold | 6 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Failure to Capture | 7 | Device |
| 2023 | Device Sensing Problem | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 21 | Device |
| 2023 | Capturing Problem | 1 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 20 | Device |
| 2023 | Activation, Positioning or Separation Problem | 1 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Undesired Nerve Stimulation | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Positioning Failure | 1 | Device |
| 2022 | Over-Sensing | 3 | Device |
| 2022 | No Pacing | 1 | Device |
| 2022 | Low impedance | 2 | Device |
| 2022 | Intermittent Capture | 2 | Device |
| 2022 | Impedance Problem | 1 | Device |
| 2022 | High impedance | 7 | Device |
| 2022 | High Capture Threshold | 9 | Device |
| 2022 | Fracture | 2 | Device |
| 2022 | Failure to Capture | 5 | Device |
| 2022 | Entrapment of Device | 1 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 19 | Device |
| 2022 | Deformation Due to Compressive Stress | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Break | 3 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Ambient Noise Problem | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2021 | Unspecified Infection | 2 | Patient |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2019 | Unstable Capture Threshold | 1 | Device |
| 2019 | Under-Sensing | 4 | Device |
| 2019 | Pacing Problem | 1 | Device |
| 2019 | Over-Sensing | 2 | Device |
| 2019 | Output above Specifications | 1 | Device |
| 2019 | No Pacing | 1 | Device |
| 2019 | Naturally Worn | 1 | Device |
| 2019 | Mechanical Problem | 2 | Device |
| 2019 | Material Perforation | 1 | Device |
| 2019 | Malposition of Device | 1 | Device |
| 2019 | Low impedance | 2 | Device |
| 2019 | Intermittent Capture | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Impedance Problem | 2 | Device |
| 2019 | High impedance | 2 | Device |
| 2019 | High Capture Threshold | 11 | Device |
| 2019 | Fracture | 3 | Device |
| 2019 | Failure to Sense | 1 | Device |
| 2019 | Failure to Capture | 13 | Device |
| 2019 | Device Sensing Problem | 4 | Device |
| 2019 | Device Dislodged or Dislocated | 25 | Device |
| 2019 | Deformation Due to Compressive Stress | 1 | Device |
| 2019 | Break | 2 | Device |
| 2019 | Ambient Noise Problem | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 47 | Device |
| 2018 | Unstable Capture Threshold | 4 | Device |
| 2018 | Under-Sensing | 3 | Device |
| 2018 | Pacing Problem | 2 | Device |
| 2018 | Pacing Intermittently | 1 | Device |
| 2018 | Over-Sensing | 1 | Device |
| 2018 | No Pacing | 1 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Intermittent Capture | 4 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Impedance Problem | 2 | Device |
| 2018 | High impedance | 8 | Device |
| 2018 | High Capture Threshold | 17 | Device |
| 2018 | Fracture | 1 | Device |
| 2018 | Failure to Sense | 1 | Device |
| 2018 | Failure to Capture | 25 | Device |
| 2018 | Device Sensing Problem | 3 | Device |
| 2018 | Device Dislodged or Dislocated | 38 | Device |
| 2018 | Device Abrasion From Instrument Or Another Object | 1 | Device |
| 2018 | Defective Component | 6 | Device |
| 2018 | Break | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Ambient Noise Problem | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 61 | Device |
| 2017 | Unstable Capture Threshold | 4 | Device |
| 2017 | Premature Discharge of Battery | 1 | Device |
| 2017 | Pacing Problem | 3 | Device |
| 2017 | Pacing Intermittently | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Malposition of Device | 1 | Device |
| 2017 | Low impedance | 3 | Device |
| 2017 | Intermittent Capture | 1 | Device |
| 2017 | Insufficient Information | 3 | Device |
| 2017 | Impedance Problem | 6 | Device |
| 2017 | High impedance | 4 | Device |
| 2017 | High Capture Threshold | 9 | Device |
| 2017 | Failure to Sense | 1 | Device |
| 2017 | Failure to Capture | 21 | Device |
| 2017 | Device Sensing Problem | 3 | Device |
| 2017 | Device Dislodged or Dislocated | 32 | Device |
| 2017 | Device Damaged by Another Device | 1 | Device |
| 2017 | Device Abrasion From Instrument Or Another Object | 1 | Device |
| 2017 | Defective Component | 2 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Ambient Noise Problem | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 33 | Device |
| 2016 | No Pacing | 2 | Device |
| 2016 | Low impedance | 3 | Device |
| 2016 | Loose or Intermittent Connection | 1 | Device |
| 2016 | Impedance Problem | 1 | Device |
| 2016 | High impedance | 2 | Device |
| 2016 | High Capture Threshold | 6 | Device |
| 2016 | Failure to Sense | 2 | Device |
| 2016 | Failure to Capture | 5 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Device Displays Incorrect Message | 1 | Device |
| 2016 | Device Dislodged or Dislocated | 9 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 4 | Device |