FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3043202
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-02888
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- January 21, 2013
- Report Date
- January 21, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- PHYSICIAN
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 THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS DUE TO A FRACTURE. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE LEAD WAS SURGICALLY ABANDONED AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146554 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| L| R | K173| 5076| 4471| 4470| 1291 |