FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3220272
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04218
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 31, 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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP, EXTERNALIZED CONDUCTORS WERE OBSERVED. THE LEAD WAS DIAGNOSTICALLY IMAGED PROPHYLACTICALLY. NO ELECTRICAL ANOMALIES WERE DETECTED. THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320198 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |