BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 740 DR-T PROMRI

    MDR report key: 3201624 · Received July 2, 2013

    Report

    Report Number
    1028232-2013-01837
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 6 MONTHS, IT WAS REPORTED THAT DURING AN ICD UPGRADE PROCEDURE, A LEAD FRACTURE WAS DISCOVERED ON THE OLD RV LEAD. THERE WERE NO ISSUES REPORTED FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301609 LUMAX 740 DR-T PROMRI ICD MRM BIOTRONIK SE & CO. KG 381461

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization