BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3943864 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13445
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 3, 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 Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP, NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING WAS OBSERVED ON STORED EGM. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421812 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2377-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR