FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2902518
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00360
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- October 3, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0458
- 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 A PARTIAL LEAD WITH THE CONNECTOR PINS MEASURING 13.4 CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT THE RETURN OF THE ENTIRE LEAD A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
PATIENT PRESENTED IN THE OR FOR CHANGE OUT DUE TO NORMAL ERI. UNDER FLUOROSCOPY EXTERNALIZED CONDUCTORS WERE NOTED. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8715 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |