BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 VR-T XL

    MDR report key: 2082851 · Received April 29, 2011

    Report

    Report Number
    1028232-2011-00987
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED BECAUSE IT COULD NO LONGER BE INTERROGATED AFTER A SHOCK DELIVERY ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T XL ICD MRM BIOTRONIK SE & CO. KG 357889

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization