BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE ST VR

    MDR report key: 4210701 · Received October 29, 2014

    Report

    Report Number
    2938836-2014-17243
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 13, 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
    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 EPISODES OF NON-SUSTAINED LEAD NOISE WERE OBSERVED VIA MERLIN.NET TRANSMISSION. MYOPOTENTIAL OVERSENSING WAS SUSPECTED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692876 ELLIPSE ST VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1277-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1