BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY DR

    MDR report key: 4140481 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05840
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    NA
    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 PATIENT FOUND UNRESPONSIVE PRESENTED IN THE EMERGENCY ROOM. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. A DEVICE REPLACEMENT WAS SCHEDULED DUE TO NORMAL ERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30109 INTEGRITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5366

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR