BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY DR RF

    MDR report key: 3925705 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15612
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 PULSE GENERATOR EXHIBITED AN EVENT OF LOSS OF VENTRICULAR CAPTURE WITHOUT THE DELIVERY OF A BACK-UP PULSE. THE PATIENT WAS DEPENDENT. THE DEVICE WAS REPROGRAMMED AND REMAINED IMPLANTED. THE PATIENT WAS IN NORMAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404861 ASSURITY DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1