BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 HF-T

    MDR report key: 2111779 · Received May 25, 2011

    Report

    Report Number
    1028232-2011-01170
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS SYS WAS REMOVED DUE TO (B)(6) AND ALL AVAILABLE INFO SUGGESTS THAT THE SYS WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 HF-T CRT-D MRM BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization