FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2924940
·
Received January 22, 2013
Report
- Report Number
- 2124215-2013-01545
- Event Type
- Injury
- Date Received
- January 22, 2013
- Date of Event
- December 17, 2012
- Report Date
- December 17, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- 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 RIGHT VENTRICULAR (RV) LEAD FRACTURED. THIS WAS DISCOVERED DURING A STANDARD IN-OFFICE APPOINTMENT. THE LEAD EXHIBITED HIGH IMPEDANCES AND LOSS OF CAPTURE. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AND WAS NOT PACER DEPENDENT. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS SURGICALLY CAPPED AND ABANDONED. A NEW COMPETITOR'S LEAD WAS SUCCESSFULLY PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29419 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Hospitalization| L| R | S201| 4092| 4457 |