BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR

    MDR report key: 4221039 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17466
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    August 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INDUCTION TEST AFTER THE DEVICE WAS IMPLANTED, THE DEVICE CHARGED, BUT NO THERAPY WAS DELIVERED. THE DEVICE CHARGED A SECOND TIME WITH THE SAME RESULT. THE PATIENT WAS CONVERTED EXTERNALLY. THE DEVICE WAS NOT USED AND WAS REPLACED. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703077 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR