FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3053167
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05634
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- December 1, 2012
- Report Date
- March 12, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND OUT-OF-RANGE (OOR) PACING IMPEDANCES > 2000 OHMS. SURGICAL INTERVENTION WAS PERFORMED WHERE THE LEAD WAS SURGICALLY ABANDONED AND A NEW RA LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155227 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L| R | E110| A135| 4470| 0158 |