BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2903962 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-02952
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 46 MONTHS, OVERSENSING WITH INAPPROPRIATE SHOCK DELIVERIES WAS REPORTED. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED. THE ICD AND THE LEADS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK