FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2890003
·
Received December 28, 2012
Report
- Report Number
- 2017865-2012-10734
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- October 10, 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
- NY
- 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 THAN AN ASYMPTOMATIC PATIENT PRESENTED TO THE OR FOR DEVICE CHANGE OUT DUE TO NORMAL ERI. EXTERNALIZED CONDUCTORS WERE OBSERVED. NO ELECTRICAL ANOMALIES WERE DETECTED. LEAD TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1590/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |