BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 DR-T

    MDR report key: 4211000 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-002184
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694641 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization