BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 HF-T

    MDR report key: 3843197 · Received June 2, 2014

    Report

    Report Number
    1028232-2014-01808
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    OUS MDR - THIS PATIENT WAS ADMITTED TO THE HOSPITAL FOR A LIFE-THREATENING INFECTION. CURRENTLY, THE INFECTION IS BEING TREATED WITH ANTIBIOTICS. AN EXPLANT OF THE SYSTEM WILL BE CONSIDERED. CURRENTLY, ALL AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IMPLANTED. THE EVENT DATE WAS NOT PROVIDED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321640 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization