FDA Adverse Event
Malfunction
Summary report: N
OPTISENSE LEAD
MDR report key: 8805630
·
Received July 18, 2019
Report
- Report Number
- 2938836-2019-06142
- Event Type
- Malfunction
- Date Received
- July 18, 2019
- Date of Event
- July 16, 2019
- Report Date
- July 18, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- UDI-DI
- 05414734502474
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND A PARTIAL LEAD WAS RETURNED IN THREE PIECES. EXTERNAL ABRASION BREACHING THE OUTER INSULATION AND EXPOSING THE OUTER COIL WAS FOUND AT 9.9-10.1 CM FROM THE CONNECTOR PIN CONSISTENT WITH FRICTION TO THE DEVICE CAN. PROCEDURAL DAMAGE TO THE OUTER INSULATION WAS ALSO NOTED IN THIS LOCATION.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597068 | OPTISENSE LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1999/46 | P000004596 | 05414734502474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |