BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 2902683 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00427
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 6, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS. ANALYSIS WAS NORMAL. NO ANOMALY 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
    9315 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4)