BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF VR

    MDR report key: 2984178 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00219
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 4, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    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.

    Additional Manufacturer Narrative · 1

    THE REPORTED HIGH HV LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND HIGH HV LEAD IMPEDANCE WAS OBSERVED. X-RAY INSPECTION IDENTIFIED A BROKEN CASE WIRE AS THE CAUSE OF THE HIGH HV LEAD IMPEDANCE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH HV LEAD IMPEDANCE WAS OBSERVED ON THE COMPETITOR LEAD. THE LEAD WAS CHANGED HOWEVER THE IMPEDANCE MEASUREMENT DID NOT IMPROVE. THE ICD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86490 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1