BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 HF-T

    MDR report key: 1241510 · Received November 20, 2008

    Report

    Report Number
    1028232-2008-01495
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BIOTRONIK, GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS REMOVED DUE TO INFECTION. THE LEADS REMAIN IN SERVICE. THE DEVICE WAS REPLACED WITH A LUMAX 340 HF-T.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization