FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 11660683
·
Received April 13, 2021
Report
- Report Number
- 2124215-2021-04781
- Event Type
- Injury
- Date Received
- April 13, 2021
- Date of Event
- February 1, 2021
- Report Date
- April 18, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- UDI-DI
- 00802526397745
- PMA / PMN Number
- P960006/S005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, PACING INHIBITION, AND INCREASED PACING THRESHOLDS. LEAD BODY DAMAGE WAS NOTED. THIS RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, PACING INHIBITION, AND INCREASED PACING THRESHOLDS. LEAD BODY DAMAGE WAS NOTED. THIS RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553223 | FLEXTEND | PERMANENT PACEMAKER ELECTRODE | DTB | BOSTON SCIENTIFIC CORPORATION | 4088 | 235504 | 00802526397745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R |