BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 1581709 · Received December 23, 2009

    Report

    Report Number
    1028232-2009-01673
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Date of Event
    November 15, 2009
    Report Date
    December 3, 2009
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P000009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER IMPACT ADVERSE EVENT REPORT, THIS DEVICE IS AT PREMATURE ERI INDICATION AND HAS BEEN REPLACED WITH A LUMAX 540 DR-T. ON 12/21/2009, THIS DEVICE WAS RETURNED TO US FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 DR-T ICD LWS BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization