BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 HF-T

    MDR report key: 2052479 · Received March 15, 2011

    Report

    Report Number
    1028232-2011-00519
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 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

    PT WAS CARDIOVERTED EXTERNALLY. FOLLOWING THE CARDIOVERSION, DEVICE INTERROGATION RESULTED IN AN ERROR MESSAGE. REP WAS UNABLE TO INTERROGATE THE DEVICE. TROUBLESHOOTING WAS UNSUCCESSFUL. RECOMMEND EXPLANTING AND RETURNING THE DEVICE. DEVICE WAS EXPLANTED THE DAY OF THE EVENT.

    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 61 YR Hospitalization