BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 4760361 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04664
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    February 4, 2015
    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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED INTO THE CLINIC WITH REDNESS AND IRRITATION AROUND THE POCKET. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD DEVELOPED AN INFECTION. THE SYSTEM WAS EXPLANTED AND REPLACED. PATIENTS CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304879 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention