BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE ST VR, DF-4 CONNECTOR

    MDR report key: 3943821 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13354
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 DEVICE DELIVERED INAPPROPRIATE THERAPY AFTER THE PATIENT PLAYED A CONTACT SPORT. PROGRAMMING CHANGES WERE DONE. PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422063 ELLIPSE ST VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1277-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR