BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 3871891 · Received June 13, 2014

    Report

    Report Number
    1028232-2014-01944
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    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

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    LEAD NOISE MANIFESTED ON LEAD DURING A SLOW VT EPISODE. DEVICE DETECTED VF DUE TO NOISE AND ABORTED THE SHOCK, UPON REDETECTION A SHOCK WAS DELIVERED TO PATIENT. ATTEMPTS TO GATHER MORE INFORMATION HAVE BEEN UNSUCCESSFUL. ALL AVAILABLE INFORMATION SUGGESTS THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349981 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other