BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY DR

    MDR report key: 4190087 · Received January 11, 2014

    Report

    Report Number
    2017865-2014-02260
    Event Type
    Malfunction
    Date Received
    January 11, 2014
    Date of Event
    July 12, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC PATIENT PRESENTED TO THE CLINIC WITH A SEIZURE. THE PULSE GENERATOR WAS FOUND TO BE IN BACKUP VVI OPERATION. A SOFTWARE DOWNLOAD WAS DONE. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21578 AFFINITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC. CRMD 5331M/S

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR