BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 DR-T

    MDR report key: 3091992 · Received May 3, 2013

    Report

    Report Number
    1028232-2013-01320
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 15, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2013 FOR AN ELECTIVE ICD POCKET REVISION. THIS DEVICE REMAINS ACTIVELY IMPLANTED AND THERE WERE NO ADVERSE EVENTS REPORTED FOR THIS PATIENT. IF ADDITIONAL INFORMATION IS OBTAINED, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193912 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization