FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3080191
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00929
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- February 25, 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
- VA
- 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 DEVICE CHANGE OUT DUE TO ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED. PATIENT WAS ASYMPTOMATIC AND NO ELECTRICAL ANOMALIES WERE NOTED. LEAD REMAINS IMPLANTED AND PATIENT TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180805 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |