BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 3920569 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14165
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THE IMPLANTABLE CARDIAC MONITOR EXHIBITED LOSS OF SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395879 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC., CRMD DM2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1