BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUSTAIN XL DR

    MDR report key: 3920627 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14230
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IMPLANT PROCEDURE, THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. AFTER THE SOFTWARE WAS DOWNLOADED NORMAL FUNCTION RESUMED. THE DEVICE HAD BEEN EXPOSED TO ELECTROCAUTERY DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397373 SUSTAIN XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2136 NA

    Patients

    Seq Age Sex Outcome Treatment
    1