BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3220290 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04211
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 7.5-12.5CM FROM THE DISTAL TIP. THE EFTE COATING WAS NOT ABRADED AT THIS LOCATION.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320226 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1