BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE ST DR, DF-4 CONNECTOR

    MDR report key: 3884722 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12103
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 AN ALERT FOR POST-PACED T-WAVE OVERSENSING WAS RECEIVED. PROGRAMMING CHANGES WERE MADE AND THE ISSUE WAS RESOLVED. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361614 ELLIPSE ST DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2277-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1