FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3213013
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10434
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 21, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS REPOSITIONED AND REMAINS IN SERVICE. 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 APPROXIMATELY TWO WEEKS POST IMPLANT, THIS RIGHT VENTRICULAR LEAD DISPLAYED INTERMITTENT LOSS OF CAPTURE. IN ADDITION, MUSCLE STIMULATION WAS OBSERVED. AN X-RAY REVEALED THIS RIGHT VENTRICULAR LEAD WAS DISLODGED. A LEAD REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REPOSITIONED AND REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313534 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |