FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2902595
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00357
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 12, 2012
- 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 Location
- AR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PARTIAL LEAD MEASURING 22.8 CM OF THE PROXIMAL CONNECTOR WAS RETURNED. MULTIPLE EXTERNAL INSULATION ABRASIONS WERE FOUND BETWEEN 15.4 CM TO 22.8 CM FROM THE CONNECTOR PIN CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. AT 19.3- 21.1 CM FROM THE CONNECTOR THE ETFE COATING OF THE SVC CONDUCTOR WAS ABRADED. AT 22-22.8 CM FROM THE CONNECTOR PIN THE ETFE COATING OF THE SVC CONDUCTOR WAS ABRADED AND THE CONDUCTOR WAS PARTIALLY MELTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, LOW SHOCK IMPEDANCE WAS OBSERVED DURING DFT TESTING. EXTERNALIZED CONDUCTORS WERE NOTED DURING THE PROCEDURE. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8791 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1591/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |