FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3212960
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09396
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 4, 2013
- Report Date
- June 5, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED. THE CAUSE OF THE COLLAPSE IS UNKNOWN.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A CHANGEOUT DEVICE PROCEDURE AFTER THE DEVICE DECLARED ERT AND THE PATIENT HAD COLLAPSED DUE TO UNKNOWN CAUSE LOSS OF CAPTURE WAS NOTED ON THIS RIGHT VENTRICULAR LEAD. EXTERNAL PACING WAS REQUIRED. THIS RIGHT VENTRICULAR LEAD REMAINS IN SITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313676 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |