BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 4072318 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16300
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    June 18, 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
    CA
    Reporter Occupation
    NURSE

    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 UNDERSENSING. SENSITIVITY WAS ADJUSTED TO PREVENT UNDERSENSING AND THE DEVICE REMAINED IMPLANTED. THE PATIENT WAS IN STABLE CONDITION DURING AND FOLLOWING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555742 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC., CRMD DM2102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR