BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1073100 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02347
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    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 THE REASON FOR RETURN WAS CONFIRMED IN THE LABORATORY. THE DAMAGE OBSERVED ON THE OUTER INSULATION WAS CAUSED BY RICTION TO THE ICD CAN. THE METAL WIRE OF THE SENSING CABLE WAS EXPOSED AND THIS DAMAGE CAUSED THE REPORTED OVERSENSING THE LEAD EXHIBITED NORMAL PACING AND LEAD INSULATION RESISTANCE. ALL OTHER MEASUREMENTS COULD NOT BE PERFORMED AS THE LEAD WAS CUT IN THE FIELD. T HIS DAMAGE WAS SUSTAINED DURING THE EXPLANT PROCEDURE AND IS NOT A RESULT OF DEFICIENCY IN MATERIALS OR WORKMANSHIP.

    Description of Event or Problem · 1

    AT FOLLOW-UP, NOISE WAS OBSERVED AND WAS REPRODUCIBLE BY MOVING THE ICD THROUGH THE SKIN. AT THE TIME THE LEAD WAS CAPPED, INSULATION DEGREDATION WAS OBSERVED ON THE LEAD. IT WAS SUSPECTED THAT THE LEAD HAD CONTACT WITH THE ICD, CAUSING DAMAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention