FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3223588
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-09910
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- May 29, 2013
- Report Date
- June 4, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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 ATRIAL (RA) LEAD EXHIBITED INTERMITTENT HIGH, OUT OF RANGE, PACING IMPEDANCE MEASUREMENTS AND NOISE WHICH THEY WERE ABLE TO REPRODUCE WITH POCKET MANIPULATION. A SURGICAL INTERVENTION WAS PERFORMED AND THIS LEAD WAS SURGICALLY ABANDONED AND CAPPED. THIS LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322228 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L| R | 4473| H210| 0185| 4554 |