IMPLANTABLE LEAD
This device is manufactured by BOSTON SCIENTIFIC CORPORATION, CPI - DEL CARIBE.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Foreign Body In Patient | 1 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Signal Artifact/Noise | 1 | Device |
| 2023 | Pacing Problem | 1 | Device |
| 2023 | Over-Sensing | 2 | Device |
| 2023 | High impedance | 2 | Device |
| 2023 | High Capture Threshold | 2 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Failure to Read Input Signal | 1 | Device |
| 2023 | Failure to Capture | 3 | Device |
| 2022 | Impedance Problem | 1 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | High Capture Threshold | 3 | Device |
| 2022 | Fracture | 2 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2019 | Pacing Problem | 1 | Device |
| 2019 | Material Integrity Problem | 2 | Device |
| 2019 | Low impedance | 1 | Device |
| 2019 | High impedance | 4 | Device |
| 2019 | High Capture Threshold | 1 | Device |
| 2019 | Failure to Select Signal | 1 | Device |
| 2019 | Failure to Capture | 2 | Device |
| 2019 | Defective Device | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Pocket Stimulation | 2 | Device |
| 2018 | Pacing Problem | 2 | Device |
| 2018 | Over-Sensing | 2 | Device |
| 2018 | Material Integrity Problem | 1 | Device |
| 2018 | High impedance | 3 | Device |
| 2018 | High Capture Threshold | 2 | Device |
| 2018 | Fracture | 2 | Device |
| 2018 | Failure to Capture | 4 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 3 | Device |
| 2018 | Defective Device | 2 | Device |
| 2018 | Capturing Problem | 5 | Device |
| 2018 | Ambient Noise Problem | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2017 | Pocket Stimulation | 3 | Device |
| 2017 | Pacing Problem | 2 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Material Integrity Problem | 3 | Device |
| 2017 | Low impedance | 1 | Device |
| 2017 | Impedance Problem | 1 | Device |
| 2017 | High impedance | 10 | Device |
| 2017 | Fracture | 6 | Device |
| 2017 | Failure to Capture | 14 | Device |
| 2017 | Electrical /Electronic Property Problem | 1 | Device |
| 2017 | Device Sensing Problem | 2 | Device |
| 2017 | Device Dislodged or Dislocated | 7 | Device |
| 2017 | Connection Problem | 1 | Device |
| 2017 | Capturing Problem | 9 | Device |
| 2017 | Ambient Noise Problem | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2016 | Pacing Problem | 1 | Device |
| 2016 | Over-Sensing | 1 | Device |
| 2016 | High impedance | 8 | Device |
| 2016 | Fracture | 4 | Device |
| 2016 | Failure to Capture | 9 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Device Dislodged or Dislocated | 4 | Device |
| 2016 | Connection Problem | 2 | Device |
| 2016 | Capturing Problem | 6 | Device |
| 2016 | Ambient Noise Problem | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Device Dislodged or Dislocated | 1 | Device |
| 2015 | Appropriate Term/Code Not Available | 1 | Device |
| 2014 | Use of Device Problem | 1 | Device |
| 2014 | Pocket Stimulation | 1 | Device |
| 2014 | Pacing Problem | 3 | Device |
| 2014 | Over-Sensing | 1 | Device |
| 2014 | Material Integrity Problem | 1 | Device |
| 2014 | Insufficient Information | 1 | Device |
| 2014 | High impedance | 7 | Device |
| 2014 | Fracture | 5 | Device |
| 2014 | Failure to Capture | 14 | Device |
| 2014 | Electrical /Electronic Property Problem | 1 | Device |
| 2014 | Difficult To Position | 2 | Device |
| 2014 | Device Sensing Problem | 1 | Device |
| 2014 | Device Dislodged or Dislocated | 17 | Device |
| 2014 | Appropriate Term/Code Not Available | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2013 | Pocket Stimulation | 3 | Device |
| 2013 | Pacing Problem | 2 | Device |
| 2013 | Migration or Expulsion of Device | 1 | Device |
| 2013 | Material Integrity Problem | 1 | Device |
| 2013 | Insufficient Information | 2 | Device |
| 2013 | High impedance | 8 | Device |
| 2013 | Fracture | 3 | Device |
| 2013 | Failure to Capture | 8 | Device |
| 2013 | Difficult to Remove | 2 | Device |
| 2013 | Difficult To Position | 1 | Device |
| 2013 | Device Sensing Problem | 3 | Device |
| 2013 | Device Dislodged or Dislocated | 11 | Device |
| 2013 | Connection Problem | 1 | Device |
| 2013 | Appropriate Term/Code Not Available | 2 | Device |
| 2010 | High impedance | 1 | Device |
| 2010 | Failure to Capture | 1 | Device |
| 2010 | Device Dislodged or Dislocated | 1 | Device |
| 2008 | Material Integrity Problem | 1 | Device |
| 2006 | Capturing Problem | 1 | Device |