BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT

    MDR report key: 3920524 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14122
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 19, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCING MUSCLE STIMULATION WAS PRESENTED IN CLINIC AFTER RECEIVING A NOTIFIER ALERT. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED BACKUP VVI MODE. AFTER A DEVICE SOFTWARE DOWNLOAD, NORMAL DEVICE FUNCTION RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396306 ACCENT IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR