BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 HF-T

    MDR report key: 1982288 · Received February 1, 2011

    Report

    Report Number
    1028232-2011-00205
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 21, 2011
    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 DEVICE WAS EXPLANTED AND REPLACED BECAUSE IT COULD NOT BE INTERROGATED.

    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 77 YR Hospitalization