FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1894549
·
Received November 10, 2010
Report
- Report Number
- 2124215-2010-16074
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 8, 2009
- Report Date
- September 9, 2009
- 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 REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED FOLLOWING THE IMPLANT PROCEDURE. IN A REVISION PROCEDURE THE NEXT DAY, THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE PATIENT STATED HE FEELS THE PACING WHEN THE DEVICE KICKS IN. HE ALSO STATED HE HAS NOT FELT WELL SINCE THE REVISION PROCEDURE, AND SUSPECTS ONE OF HIS LEADS HAS DISLODGED AGAIN. TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY OF MUSCLE STIMULATION, AND REFERRED THE PATIENT TO A PHYSICIAN TO HAVE A SYSTEM CHECK PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Life Threatening| R | 4456| S403| 4479 |