BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY XL DR

    MDR report key: 4143077 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05626
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 10, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
    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 INFO PROVIDED BY MFR, 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 DURING A FOLLOW UP, THE DEVICE PRESENTED AN ERROR MESSAGE. THE REP ELECTED TO INVESTIGATE THE LATEST BATTERY DATA AND MAKE A DECISION ON REPLACEMENT AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31737 IDENTITY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION 5376

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR