FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984216
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00297
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 4, 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 Location
- NC
- 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 NORMAL FOLLOW UP, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA IMAGING. NO ELECTRICAL ANOMALIES WERE NOTED. PATIENT WAS ASYMPTOMATIC. LEAD REMAINS IMPLANTED AND PATIENT TO BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED INDICATES THAT DURING A NORMAL GENERATOR CHANGE-OUT, THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85803 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |