FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2170293
·
Received July 20, 2011
Report
- Report Number
- 2124215-2011-09857
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- May 31, 2011
- Report Date
- May 31, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BOTH LEADS WERE DISCARDED AT THE HOSPITAL AND ARE NOT AVAILABLE FOR RETURN. 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 PATIENT REPORTS BOTH IMPLANTIBLE PACING LEADS INSULATION BECAME DAMAGED FROM RUBBING AGAINST HIS RIB. THE NEXT DAY BOTH LEADS WERE FOUND TO BE FRACTURED VIA X-RAY AT THE SUTURE SLEEVE SITE, WHICH TRIGGERED THE LEAD SAFETY SWITCH. IT WAS SUSPECTED THAT THE SUTURE SLEEVES ON THE LEADS WERE TIED TOO TIGHT. THE LEADS WERE SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE 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 | 65 YR | Hospitalization| L| R | 4470| S404| 4457 |