FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3243298
·
Received July 23, 2013
Report
- Report Number
- 2124215-2013-11772
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS AND NO SENSING RESULTING IN LACK OF PACING. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343976 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | E110| 0185| 4470 |