BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY SR

    MDR report key: 4143190 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05676
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 27, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PULSE GENERATOR WAS IN BACK-UP VVI SAFETY OPERATION MODE. THE ISSUE WAS RESOLVED WITH A SUCCESSFUL USER SOFTWARE DOWNLOAD. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31844 AFFINITY SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC. CRMD 5130L

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR