BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 340 HF-T

    MDR report key: 1565391 · Received December 22, 2009

    Report

    Report Number
    1028232-2009-01657
    Event Type
    Death
    Date Received
    December 22, 2009
    Date of Event
    November 4, 2009
    Report Date
    December 1, 2009
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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. THE DEVICE WILL NOT BE RETURNED TO BIOTRONIK. 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

    AFTER AN IMPLANTATION TIME OF ABOUT 4 1/2 MONTHS, IT WAS REPORTED THAT THE PATIENT EXPIRED, POSSIBLY DUE TO VF UNDERSENSING. NO FURTHER INFORMATION HAS BEEN REPORTED TO BIOTRONIK SO FAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death