BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX TD 65/18

    MDR report key: 1032067 · Received April 21, 2008

    Report

    Report Number
    1028232-2008-00381
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER REP., THIS LEFT-SIDED SYSTEM WAS REMOVED DUE TO INFECTION AND EROSION. PT. HAS VERY THIN SKIN AND THIS IS THE SECOND INFECTION FOR THE PT. AND THE FIRST EROSION. THE LEAD WOULD NOT COME OUT AND WILL BE LASERED OUT IF NEED BE. THEREFORE, IT WILL NOT BE RETURNED TO BINC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX TD 65/18 ICD LEAD LWS BIOTRONIK GMBH AND CO. 351338

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization