BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT DR RF

    MDR report key: 3884748 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12108
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALERTS FOR LOW, OUT OF RANGE HV LEAD IMPEDANCE WERE RECEIVED; THE FIRST BEING TWO YEARS AGO. IMPEDANCE HAS BEEN MAINLY STABLE AND IN-RANGE WITH OCCASIONAL LOW MEASUREMENTS. THE SYSTEM REMAINS IMPLANTED AND REMOTE MONITORING WILL CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361387 CURRENT DR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)