BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 HF-T

    MDR report key: 1243036 · Received November 20, 2008

    Report

    Report Number
    1028232-2008-01489
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BIOTRONIK BMBH AND CO.
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS DEVICE HAD INTERMITTENT OUTPUT AND PREMATURE EOS WARNING WITH MORE THAN 200 CHARGES. SYSTEM REMOVED: LINOX SD 65/16, MDR 1028232-2008-01571.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 HF-T CRT-D MRM BIOTRONIK BMBH AND CO. 355263

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization