FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 2171616
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-09875
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 3, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT BELIEVED THE INCISION LOCATION WAS INFECTED. THERE WAS A STRING COMING OUT OF THE INCISION. THE INCISION IS RED AND WHEN THE INCISION IS PRESSED ON, BODILY FLUIDS COME OUT. THE PATIENT'S PHYSICIAN IS AWARE OF THE STRING AND INFORMED THE PATIENT THAT IT WILL GO AWAY. NO ADVERSE PATIENT EFFECTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | 4472| 4473| S603 |