BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR

    MDR report key: 3920601 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14223
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 14, 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
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PACEMAKER DEPENDENT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW UP. DURING INTERROGATION WHEN AN ATRIAL CAPTURE TEST WAS PERFORMED, IT WAS NOTED THAT THE PULSE GENERATOR EXHIBITED LOSS OF VENTRICLE CAPTURE. THE PATIENT EXPERIENCED DIZZINESS AND LIGHT HEADEDNESS DURING THE TEST. THE PATIENT WAS FINE AFTER THE TEST WAS STOPPED. THE DEVICE REMAINED IMPLANTED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396011 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2112 NA

    Patients

    Seq Age Sex Outcome Treatment
    1