FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984361
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00335
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 20, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
EXTERNAL INSULATION ABRASION WAS FOUND AT 9.5-9.9CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 11.2-13.2CM FROM THE DISTAL END. INTERNAL INSULATION ABRASIONS WERE FOUND BETWEEN 29.0-29.7CM FROM THE DISTAL END. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASIONS FOUND AT 11.8-12.9 CM FROM THE DISTAL END. THE ETFE COATING WAS ABRADED AT THIS LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE DEVICE CHANGE OUT, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. ELECTRICAL FUNCTION WAS TESTED AND NO ANOMALIES WERE DETECTED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87937 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |