BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2914117 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03120
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    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

    ON (B)(6) 2012, THIS DEVICE COULD NOT BE INTERRUPTED. THE DEVICE SUCCESSFULLY TRANSMITTED TO THE HOME MONITORING SERVICE CENTER ON (B)(6) 2012 WITH NO ANOMALIES REPORTED. ON (B)(6) 2012 - THIS DEVICE WAS EXPLANTED, AND THE COMPETITIVE RV WAS CAPPED ON (B)(6) 2012.

    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 60 YR Hospitalization