BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3854575 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11597
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    March 18, 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
    WA, US
    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 NOISE WAS OBSERVED VIA REVIEW OF EGMS. PATIENT WAS ASYMPTOMATIC. PLANS WERE MADE TO BRING THE PATIENT IN AND DISCUSS PROGRAMMING CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332019 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 1688TC/46, DM71480