FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2173634
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-11528
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND AT THIS TIME OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD DISPLAYED PACING IMPEDANCES OF GREATER THAN 2,500 OHMS. A LEAD FRACTURE WAS SUSPECTED. A LEAD REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS CUT AND CAPPED AND A NEW LEAD WAS IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
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 | Life Threatening| R | S603| 4457| 4470 |