FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2052636
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04392
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD DISLODGED APPROXIMATELY SIX HOURS AFTER IT WAS IMPLANTED. ANOTHER SURGICAL PROCEDURE WAS DONE TO REPOSITION THE LEAD AND ENSURE THAT THE PATIENT HAS THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE EXTRA SURGICAL PROCEDURE.
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 | 75 YR | Required Intervention | S603| 4470| 4137 |