BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR RF

    MDR report key: 3910974 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12956
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    February 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF HIGH, OUT OF RANGE HV LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE HIGH, OUT OF RANGE HV LEAD IMPEDANCE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED FOR ROUTINE FOLLOW UP THE DEVICE EXHIBITED AN ALERT FOR HIGH, OUT OF RANGE, HV LEAD IMPEDANCE. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT COMPLICATION TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386488 CURRENT VR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention (B)(4)