BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2844891 · Received November 2, 2012

    Report

    Report Number
    1028232-2012-02762
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P00009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 - ADDED THE ANALYSIS TEXT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. IT WAS REPORTED THAT A REPROGRAMMING OF THE DEVICE SOLVED THE PROBLEM. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE DEVICE WAS FOUND TO BE IN BACK-UP MODE UPON INTERROGATION. PT IS CURRENTLY UNDERGOING RADIATION TREATMENT. DEVICE WAS RE-INITIALIZED AND PROGRAMMED BACK TO ORIGINAL SETTINGS. A FULL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2012 - PT JUST FINISHED RADIATION THERAPY AND DEVICE REGISTERED ERI EVEN THOUGH IT WAS BOL1 IN (B)(4). TECHNICAL SERVICES RECOMMENDED EXPLANT/REPLACEMENT BUT TRIED TO RESET AS WELL. THE RESET WAS UNSUCCESSFUL. ON (B)(6) 2012 - THIS DEVICE WAS EXPLANTED ON (B)(6) 2012 AND REPLACED WITH A CRT-D.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization