BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2950127 · Received February 8, 2013

    Report

    Report Number
    2938836-2013-00035
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 4, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN TWO PARTS. EXTERNAL INSULATION ABRASIONS WERE FOUND AT 33.5CM - 34.1CM AND 36.6 CM - 36.8CM FROM THE DISTAL TIP, CONSISTENT WITH FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, DEVICE INTERROGATION REVEALED POSSIBLE OUTPUT CIRCUIT DAMAGE WITH MULTIPLE ABORTED SHOCKS. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54479 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR V-193 316917