BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 300 HF-T

    MDR report key: 2190070 · Received June 29, 2011

    Report

    Report Number
    1028232-2011-01448
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 24, 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 30 MONTHS, IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THIS DEVICE WAS EXPLANTED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 300 HF-T CRT-D MRM BIOTRONIK, SE & CO KG 355262

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization