FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2780641
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-13041
- Event Type
- Injury
- Date Received
- October 10, 2012
- Date of Event
- September 13, 2012
- Report Date
- September 13, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 BOTH THIS RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD DISLDOGED AND RESULTED IN PACING INHIBITION AND ASYSTOLE FOR EQUAL TO OR GREATER THAN TWO SECONDS. AS A RESULT BOTH LEADS WERE SUCCESSFULLY REPOSITIONED AND NOW REMAIN IN SERVICE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| L| R | 4457| 4480| K063 |