BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 1031578 · Received January 11, 2008

    Report

    Report Number
    1028232-2007-00536
    Event Type
    Malfunction
    Date Received
    January 11, 2008
    Date of Event
    December 3, 2007
    Report Date
    December 12, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LEAD WAS EXPLANTED DUE TO LOSS OF SENSING AND CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK GMBH AND CO 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization