FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2973432
·
Received February 21, 2013
Report
- Report Number
- 2938836-2013-00159
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 24, 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
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR NORMAL ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. NO ELECTRICAL ANOMALIES WERE DETECTED. PATIENT WAS ASYMPTOMATIC. THE LEAD WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75561 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |