BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVIGATION SOFTCORD CRANIAL

    MDR report key: 2818443 · Received October 31, 2012

    Report

    Report Number
    8043933-2012-00018
    Event Type
    Death
    Date Received
    October 31, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETE EVALUATION NOT POSSIBLE AT THIS POINT OF TIME AS NEITHER THE DEVICE IN QUESTION NOR FURTHER RELEVANT DETAILS FROM THE HOSPITAL REGARDING THIS SURGERY ARE CURRENTLY NOT AVAILABLE TO BRAINLAB. FOR AVOIDANCE OF DOUBT: NO REMEDIAL ACTION DEFINED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION CURRENTLY AVAILABLE TO BRAINLAB: A CRANIAL BIOPSY WAS PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SYSTEM. DURING THE PROCEDURE THE SURGEON APPARENTLY: USED A NON-BRAINLAB BIOPSY NEEDLE AND ATTACHED IT WITH A NAVIGATIONAL REFERENCE ARRAY TO USE IT WITH THE BRAINLAB NAVIGATION SYSTEM; PERFORMED A CALIBRATION OF THE BIOPSY NEEDLE; TOOK SAMPLES OF THE TUMOR; SAW BLOOD ON THE NEEDLE AFTER REMOVING THE NEEDLE FROM AN ATTEMPT TO TAKE ONE OF THE SAMPLES; CONTINUED WITH THE PROCEDURE AND TOOK SAMPLES IN DIFFERENT LOCATIONS. FOLLOWING THE SURGERY THE PATIENT WAS FINE FOR ABOUT 6 HOURS, THEN THE SITUATION WORSENED. THE PATIENT DIED ABOUT 8 HOURS FOLLOWING THE SURGERY. AT THIS POINT OF TIME FURTHER INFORMATION FROM THE HOSPITAL REGARDING RELEVANT DETAILS OF THIS SURGERY IS NOT AVAILABLE TO BRAINLAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATION SOFTCORD CRANIAL IMAGE GUIDED SURGERY SYSTEM/ STEREOT. HAW BRAINLAB AG UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death