FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2902679
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00350
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 20, 2012
- 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
EXTERNALIZED CONDUCTORS DUE TO EXTERNAL INSULATION ABRASION WERE FOUND AT 8.5-14.2CM FROM THE DISTAL END. THE SILICONE INSULATION WAS ABRADED AND THE SENSING CONDUCTORS WERE VISIBLE. THE ETFE COATING WAS INTACT AT THE SAME LOCATION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE NOTED VIA X-RAY. ALL ELECTRICAL MEASUREMENTS WERE NORMAL. LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8522 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |