BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2190115 · Received June 30, 2011

    Report

    Report Number
    1028232-2011-01406
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PAINLESS SHOCK IMPEDANCE OF GREATER THAN 150 OHMS NOTED AT PREDISCHARGE. MEASUREMENT WAS ATTEMPT SEVERAL TIMES WITH ALL MEASUREMENTS SHOWING >150 OHMS. EXPECTED NUMBERS NOTED (B)(6) WITH LEAD CHANGE-OUT. CHEST X-RAY SUGGESTS THE (B)(4) PIN MAY NOT BE FULLY INSERTED. THIS DEVICE WAS EXPLANTED AND REPLACED.

    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 64 YR Hospitalization