FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984365
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00355
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 29, 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 Location
- MA
- 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 THE DEVICE AND RV LEAD WERE REPLACED DUE TO A HV IMPEDANCE ISSUE. REVIEW OF THE SESSION RECORD SHOWED AN ALERT FOR OUTPUT CIRCUIT DAMAGE AND LOW HV LEAD IMPEDANCE. THERAPY WAS DELIVERED INAPPROPRIATELY FOR SVT. AFTER THE INITIAL SHOCK, NOISE WAS SEEN ON THE P/S PORTION OF THE LEAD. DEVICE CONTINUED TO ATTEMPT TO DELIVER THERAPY BUT WAS ABORTED MULTIPLE TIMES DUE TO POSSIBLE HV CIRCUIT DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87690 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1591/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | V-268, 372458 |