BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 3920779 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14383
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING SYNCOPE. THE PATIENT WAS EXTERNALLY PACED. THE PULSE GENERATOR EXHIBITED LOSS OF VENTRICULAR CAPTURE. THE DEVICE WAS REPROGRAMMED TO FIXED OUTPUT AND AUTO CAPTURE WAS NOT RECOMMENDED FOR THIS PATIENT. THE PATIENT WOULD BE CLOSELY MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396939 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention