BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX TD 65/16

    MDR report key: 1060878 · Received June 13, 2008

    Report

    Report Number
    1028232-2008-00635
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    February 29, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED WITHOUT DOCUMENTATION. PER BIOTRONIK REP CRAIG ROBINSON, THIS LEAD WAS DISCOVERED TO BE DISLODGED POST-OP. THE PHYSICIAN REMOVED THE LEAD AND REPLACED IT WITH AN ACTIVE FIXATION LINOX SD 65/16. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX TD 65/16 ICD LEAD LWS BIOTRONIK, INC. 351338

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization