BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 HF-T

    MDR report key: 2233132 · Received July 22, 2011

    Report

    Report Number
    1028232-2011-01654
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT (B)(6), IT WAS REPORTED THAT THE ICD COULD NO LONGER BE INTERROGATED. NO DETERIORATION OF THE PT'S HEALTH WAS REPORTED. THE DEVICES WERE EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization