FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984470
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00338
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 14, 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
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
AN EXTERNAL INSULATION ABRASION WAS NOTED AT 22.1-22.2CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WAS NOTED AT 12.0-15.9CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION. AN INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 6.2-6.7CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED IN TWO AREAS VIA DIAGNOSTIC IMAGING. THE PATIENT WAS ASYMPTOMATIC. ELECTRICAL FUNCTION WAS TESTED AND NO ANOMALIES WERE DETECTED. LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87489 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |