BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4143216 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05684
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 8, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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 TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: A COMPLETE ANALYSIS COULD NOT BE PERFORMED AS THE PACKAGING IN QUESTION WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGING OF A DEVICE WAS FOUND TO BE OPENED DURING AN IMPLANT PROCEDURE. ANOTHER DEVICE WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31864 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC. CRMD PM2212

    Patients

    Seq Age Sex Outcome Treatment
    1