FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1950856
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22592
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- October 4, 2010
- Report Date
- November 18, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD WAS FRACTURED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD WAS SURGICALLY CAPPED AND A NEW COMPETITOR'S PRODUCT WAS IMPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | 5076| 4087| 0157| T125| 4088 |