FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 3090161
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01044
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- March 5, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW UP, EXTERNALIZED CONDUCTORS BETWEEN SVC-RV COILS WERE SEEN UNDER X-RAY. NO ELECTRICAL ANOMALY WAS OBSERVED. THE LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192383 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |