BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 VR-T

    MDR report key: 2222406 · Received July 15, 2011

    Report

    Report Number
    1028232-2011-01590
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BIOTRONIK SE & CO, KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 19 MONTHS, ARTIFACTS WERE REPORTED. NO DETERIORATION OF THE PATIENT'S HEALTH WAS REPORTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 VR-T ICD LWS BIOTRONIK SE & CO, KG 360348

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization