FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1952261
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23576
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 1, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- 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 THERE WERE CABLES PROTRUDING OUT OF THIS PATIENT'S GENERATOR INCISION SITE. THE PATIENT HAD CONTACTED THEIR PHYSICIAN; HOWEVER, HAD NOT HEARD BACK FROM THEM. BOSTON SCIENTIFIC'S PATIENT SERVICES RECOMMENDED THAT THE PATIENT BE EVALUATED BY A MEDICAL PROFESSIONAL. THE FIELD REPRESENTATIVE WAS CONTACTED AND AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Life Threatening | 4457| S603| 4470 |