FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 3210653
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03294
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- March 27, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- 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 THAT DURING ROUTINE DEVICE CHANGE-OUT DUE TO NORMAL ERI, IT WAS NOTED THAT UNDER FLUOROSCOPY, THERE MAY- BE EXTERNALIZED CONDUCTORS ON THE LEAD. THE ELECTRICAL MEASUREMENTS WERE NORMAL. THE LEAD REMAINS IMPLANTED. ON FURTHER REVIEW OF X-RAY, FLUORO AND CINE, THE CONDUCTORS DO NOT APPEAR TO BE EXTERNALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311769 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |