BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACDENT DR

    MDR report key: 4084226 · Received January 10, 2014

    Report

    Report Number
    2017865-2014-01436
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    July 5, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE IN THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXG SHOWED THAT THE DEVICE EXHIBITED LOSS OF CAPTURE WITH NO INDICATION OF RELIEF PACING, AND ONLY THE PACING SPIKES IN UNIPOLAR MODE CAN BE SEEN. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18234 ACDENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2112

    Patients

    Seq Age Sex Outcome Treatment
    1