BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY AFX DR

    MDR report key: 4121692 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07611
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 30, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS RESOLVED BY SUCCESSFUL SOFTWARE DOWNLOAD. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32441 INTEGRITY AFX DR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5342

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR