BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3210670 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03279
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 19, 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
    NC
    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 INDUCTION TESTING WITH A NEW ICD, LOW HIGH VOLTAGE LEAD IMPEDANCE WAS NOTED. AN INSULATION ANOMALY BEHIND THE COIL WAS NOTED. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310349 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1590/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR (B)(4)