BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUSTAIN XL DR

    MDR report key: 3920698 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14311
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 9, 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 Location
    BA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD REPOSITIONING PROCEDURE, THE PULSE GENERATOR EXHIBITED BACKUP VVI MODE AFTER SUSPECTED ELECTROCAUTERY INTERACTION. AFTER A DEVICE SOFTWARE DOWNLOAD, THE DEVICE RESUMED NORMAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396899 SUSTAIN XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2136 NA

    Patients

    Seq Age Sex Outcome Treatment
    1