FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3052625
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-04379
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD
- 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 THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND PACING INHIBITON ALONG WITH HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. SUBSEQUENTLY THE LEAD WAS SURGICALLY ABANDONED DURING A DEVICE CHANGE OUT PROCEDURE. NO ADDITIONAL ADVERSE PAITENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154419 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| L| R | 0184| E141| T167| 4472 |