FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1950445
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22423
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 17, 2010
- Report Date
- November 17, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A LEAD REVISION WAS PERFORMED AND THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL INFORMATION IS AVAILABLE AND THIS LEAD REMAINS IMPLANTED. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY FOLLOWING THE IMPLANTATION OF THIS RIGHT VENTRICULAR (RV) LEAD, LOSS OF CAPTURE WAS OBSERVED. A CHEST X-RAY WAS TAKEN AND REVEALED THAT THIS LEAD HAD DISLODGED. 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 | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |