BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2582878 · Received May 17, 2012

    Report

    Report Number
    1028232-2012-01184
    Event Type
    Malfunction
    Date Received
    May 17, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 3, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WOULD NOT INTERROGATE AFTER NUMEROUS TROUBLESHOOTING ATTEMPTS. EXPLANT WAS RECOMMENDED. ON 05/14/2012 - AS OF TODAY, ALL AVAILABLE INFO SUGGESTS THIS DEVICE REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR