FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3053613
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05715
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 27, 2013
- Report Date
- March 28, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH. DEVICE INTERROGATION NOTED SOME PAUSES IN PACING AND REVEALED THE DEVICE WAS RETRY MODE. AN X-RAY REVEALED THE LEAD HAD MICRODISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156625 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization | 4470| 4471| S606 |