FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3211328
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08656
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 7, 2013
- Report Date
- May 7, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- 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 OUT-OF-RANGE (OOR) IMPEDANCES OF GREATER THAN 2500 OHMS, AS WELL AS NOISE AND OVERSENSING. AS A RESULT THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309422 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| L| R | 4472| S606| 4473 |