BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3220288 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04204
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 16, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    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. EXTERNAL INSULATION ABRASION WAS FOUND AT 5.2-6.3CM FROM THE END OF THE IS-1 CONNECTOR PIN. A FRACTURE OF THE CONDUCTORS WAS FOUND AT 11.2CM FROM THE END OF THE SVC CONNECTOR PIN CONSISTENT WITH FATIGUE. THIS FRACTURE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF HIGH SHOCK IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT WHEN THE LEAD WAS CONNECTED TO THE DEVICE THE THRESHOLD WAS HIGH AND THE SHOCK IMPEDANCE WAS OUT OF RANGE. IT WAS ALSO NOTED THAT A DAMAGED INSULATION WAS OBSERVED. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319460 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1