FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2913724
·
Received January 14, 2013
Report
- Report Number
- 2124215-2013-00167
- Event Type
- Injury
- Date Received
- January 14, 2013
- Date of Event
- December 28, 2012
- Report Date
- December 28, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS IMPLANTED WITHOUT FURTHER COMPLICATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOUR DAYS POST-IMPLANT, THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD UNDERWENT A LEAD REVISION PROCEDURE. THE RV LEAD WAS REPOSITIONED DUE TO A PERFORATION OF THE MYOCARDIUM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21071 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |