BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 VR-T

    MDR report key: 2082763 · Received April 29, 2011

    Report

    Report Number
    1028232-2011-00988
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    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 IMPLANT DURATION OF APPROXIMATELY 47 MONTHS THIS DEVICE WAS EXPLANTED BECAUSE IT COULD NOT BE INTERROGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T ICD MRM BIOTRONIK SE & CO. KG 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization