BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 1082441 · Received July 21, 2008

    Report

    Report Number
    1028232-2008-00762
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE. PER OOS, THE PHYSICIAN "REPLACED THE LINOX LEAD BECAUSE THE SCREW WOULD NOT RETRACT UPON TRYING TO REPOSITION." THIS LEAD WAS REPLACED WITH A LINOX SD 65-18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK GMBH AND CO. 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization