BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 HF-T

    MDR report key: 2860349 · Received November 5, 2012

    Report

    Report Number
    1028232-2012-02720
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    August 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS ICD WAS EXPLANTED AND REPLACED DUE TO EOS INDICATION. THERE WERE NO ADVERSE PT EFFECTS REPORTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization