FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3211152
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-10132
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- February 6, 2013
- Report Date
- May 1, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 PRODUCT WAS PART OF A SYSTEM THAT EXPERIENCED MIGRATION AND PRE-EROSION, RESULTING IN A REVISION THREE MONTHS LATER DUE TO INFECTION AND FULL EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309566 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| L| R | 1241| 4512| 4592| H145| 4457 |