BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX TD 65/18

    MDR report key: 1457525 · Received June 22, 2009

    Report

    Report Number
    1028232-2009-00855
    Event Type
    Malfunction
    Date Received
    June 22, 2009
    Date of Event
    May 18, 2009
    Report Date
    May 20, 2009
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE (B) (4). THE LEAD WAS REMOVED BECAUSE, IT WAS SENSING A LOT OF NOISE. THIS DEVICE WAS REPLACED WITH A LINOX SD 65/18, (B) (4). PER REP, THE PHYSICIAN THOUGHT THAT HE SAW BLOOD UNDER THE INSULATION OF THE LEAD. THE SCREW IN THE DEVICE HEADER DID NOT SECURE THE LEAD PROPERLY. (B) (4) FEELS THIS MIGHT HAVE CONTRIBUTED TO THE NOISE ON THE LEAD. LUMAX 340 DR-T, (B) (4), MDR 1028232-2009-000855. LINOX TD 65/18, (B) (4), MDR 1028232-2009-00681.

    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 56 YR Hospitalization