FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 3210785
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03303
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 6, 2013
- 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
- MS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EXTERNAL INSULATION ABRASION WAS FOUND AT 13.2-13.9CM FROM DISTAL TIP, CONSISTENT TO FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THE SAME LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE UPGRADE DUE TO NORMAL ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUORO. PATIENT WAS ASYMPTOMATIC AND NO ELECTRICAL ANOMALIES WERE NOTED HOWEVER PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311336 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |