BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 3920782 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14388
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO THE CLINIC FOR FOLLOW UP, THE PULSE GENERATOR EXHIBITED A DIAGNOSTICS ANOMALY. AFTER THE PRODUCT CODE WAS RELOADED, NORMAL DEVICE FUNCTION RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396940 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR