FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242808
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06059
- Event Type
- Malfunction
- Date Received
- September 10, 2011
- Date of Event
- July 28, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- 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 AT ROUTINE ICD REPLACEMENT, FLUORO IMAGE SHOWED TWO CONDUCTOR CABLES OUTSIDE OF THE INSULATION ABOVE THE RV COIL. THE LEAD REMAINS IMPLANTED AND FUNCTIONING FOR NOW UNTIL REPLACEMENT CAN BE SCHEDULED. THE PHYSICIAN IS AWARE OF THE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |