FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1962304
·
Received January 18, 2011
Report
- Report Number
- 2124215-2011-00735
- Event Type
- Injury
- Date Received
- January 18, 2011
- Date of Event
- February 2, 2010
- Report Date
- December 17, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
TO DATE, INFORMATION SUGGESTS THIS LEAD HAD NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. THE INVESTIGATION REMAINS OPEN AT THIS TIME, IN ORDER TO SEEK ADDTIIONAL INFORMATIONFROM THE LOCAL AREA SALES REPRESENTATIVE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD HAD BECOME DISLODGED MULTIPLE TIMES, BUT NOT PREVISOULY REPORTED BY THE LOCAL AREA SALES REPRESENTATIVE. THERE WERE NO ADVERSE PATIENT SYMPTOMS BEYOND THE NEED FOR SURGICAL INTERVENTION.
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 | 59 YR | Required Intervention | 4470 |