FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1950602
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-23628
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 17, 2010
- Report Date
- December 9, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SUBSEQUENT INFORMATION INDICATES THAT THE LOCAL FIELD REPRESENTATIVE FOLLOWED UP WITH THE PATIENT'S CLINIC. THE BLUE WIRES THAT THE PATIENT WAS SEEING WERE ACTUALLY HIS STITCHES THAT HAD NOT YET BEEN REMOVED.
Additional Manufacturer Narrative · 1
AS OF TODAY, AVAILABLE EVIDENCE INDICATES THAT THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD HAD TWO BLUE WIRES STICKING OUT OF HIS INCISION FROM THE IMPLANT PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Life Threatening | N119| 4469| 0185| MISMATCH |