BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART TD 65/18

    MDR report key: 2901640 · Received January 2, 2013

    Report

    Report Number
    1028232-2012-03453
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS REMOVED AND REPLACED DUE TO DISLODGEMENT. THERE WERE NO ADVERSE PT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFO BE RECEIVED, THIS WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806 LINOX SMART TD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 359074

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization