BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMOS VR-T

    MDR report key: 1221023 · Received November 3, 2008

    Report

    Report Number
    1028232-2008-01291
    Event Type
    Death
    Date Received
    November 3, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE INSPECTION OF THE RETURNED DOCUMENTS SHOWED NO INDICATION FOR A DEVICE MALFUNCTION. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PREFORMED 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. REVIEW OF THE AVAILABLE INFO INDICATED A NORMAL DEVICE BEHAVIOR.

    Description of Event or Problem · 1

    OUS MDR. IT WAS REPORTED THAT THE PT PRESENTED WITH CHEST PAIN TO A AND E IN 2008. PT WAS PRONOUNCED DEAD AT 13:16 PM. IMPLANT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS VR-T ICD LWS BIOTRONIK GMBH AND CO 353219

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death