BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMOS VR-T

    MDR report key: 1000965 · Received February 20, 2008

    Report

    Report Number
    1028232-2008-00098
    Event Type
    Death
    Date Received
    February 20, 2008
    Date of Event
    February 13, 2007
    Report Date
    January 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. IN SUMMARY, THERE IS NO INDICATION OF A MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR. IT WAS REPORTED THAT THE PATIENT HAS DIED. THE IMPLANTATION PERIOD IS UNKNOWN. ACCORDING TO THE CLINICAL INVESTIGATOR, THERE IS NO CONNECTION BETWEEN THE DEATH OF THE PATIENT AND THE ICD.

    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 YR Other