BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 HF-T

    MDR report key: 2110383 · Received April 25, 2011

    Report

    Report Number
    1028232-2011-00928
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    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 IMPLANT DURATION OF ABOUT 9 MONTHS, THE ICD WAS EXPLANTED DUE TO OVERSENSING WITH INAPPROPRIATE SHOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 HF-T CRT-D MRM BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization