FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3212603
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10169
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 31, 2013
- Report Date
- May 31, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- 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 THIS CHRONIC RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE FRACTURED. A REVISION PROCEDURE WAS PERFORMED AND THE RA LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312051 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| L| R | 4470| MISMATCH| N119| 4471| 347351| 4555| 4592| 4543 |