BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERLIN AT HOME RF

    MDR report key: 3920422 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14024
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DRG
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 TRANSMITTER WAS NOT RESPONDING. THE AC ADAPTER PRODUCED A BURNING SMELL. THE TRANSMITTER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397626 MERLIN AT HOME RF PACEMAKER DATA TRANSMITTER DRG ST. JUDE MEDICAL, INC., CRMD EX1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1