FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2171535
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10350
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- May 30, 2011
- Report Date
- June 5, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING REVISION PROCEDURE THE STYLET CAME OUT THRU THE LUMEN INTO OUTER INSULATION OF THE LEAD. THIS LEAD WAS EXPLANTED AND A NEW RIGHT ATRIAL (RA) LEAD WAS SUCCESSFULLY IMPLANTED. 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 PATIENT IMPLANTED WITH THIS RIGHT ATRIAL (RA) LEAD EXHIBITED SYMPTOMS OF TWIDDLER'S SYNDROME, RESULTING IN THE DISLODGEMENT OF THE LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS 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 | 52 YR | Required Intervention | 4076| 7278| 4470| 7120| 6947 |