BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 4153539 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16500
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632094 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention