BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIA DR-T

    MDR report key: 2842083 · Received November 15, 2012

    Report

    Report Number
    1028232-2012-02866
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    September 21, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED AND REPLACED DUE TO ADHESIONS AND KELOID SCARRING. THE PATENT WAS COMPLAINING OF EXTREME PAIN. THE HOSPITAL RETAINED THE DEVICES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIA DR-T PACEMAKER DTB BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization