BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 HF-T

    MDR report key: 1252386 · Received December 4, 2008

    Report

    Report Number
    1028232-2008-01591
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    September 30, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING 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

    PER STUDY, ADVERSE EVENT FORM, THIS DEVICE FAILED TO CONVERT DURING DEFIBRILLATION TESTING. DEVICE STILL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 HF-T CRT-D MRM BIOTRONIK GMBH AND CO. 355263

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization