FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2172966
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10543
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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 THIS PRODUCT WAS FOUND TO BE ERODING THROUGH THE SKIN. IT WAS REPORTED THAT THERE WOULD BE A SYSTEM EXPLANT PROCEDURE APPROXIMATELY FOUR DAYS LATER. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED, AND THE PRODUCTS HAVE NOT BEEN RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Life Threatening | 1298| 4087| 4088 |