BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEKSELL STEREOTACTIC SYSTEM - MPS ARC

    MDR report key: 16145661 · Received January 12, 2023

    Report

    Report Number
    9612186-2023-00002
    Event Type
    Death
    Date Received
    January 12, 2023
    Date of Event
    January 3, 2023
    Report Date
    May 12, 2025
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    HAW
    UDI-DI
    07340048305600
    PMA / PMN Number
    K152558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. A PATIENT FROM PARAGUAY WAS IMPLANTED WITH TWO DEEP BRAIN STIMULATION ELECTRODES USING A LEKSELL STEREOTACTIC SYSTEM, INOMED MICRODRIVE AND DBS GUIDE TUBES AND BOSTON SCIENTIFIC DBS LEADS. A BLEED OCCURRED WHICH LED TO THE PATIENT BEING PLACED IN INTENSIVE CARE POSTOPERATIVELY AND LATER DIED. THE NEUROSURGEON SUSPECTS THAT THE UNFORTUNATE OUTCOME WAS CAUSED BY A PREVIOUS MEDICAL CONDITION OF THE PATIENT. THE LEKSELL STEREOTACTIC SYSTEM HAS BEEN CHECKED REGARDING MECHANICAL ACCURACY, BOTH AT ELEKTA AND AT FREDRIKSSONS VERKSTÄDER AB AS A CERTIFIED VERIFICATION AND NO FAULTS COULD BE FOUND. THE LEKSELL STEREOTACTIC SYSTEM WAS FOUND TO BE WORKING AS DESIGNED AND INTENDED AND WAS NOT SUSPECTED TO BE FAULTY BY THE USER SINCE THE TARGET WAS REACHED CORRECTLY ON BOTH SIDES.

    Additional Manufacturer Narrative · 0

    UNFORTUNATELY, DUE TO ADMINISTRATIVE ERRORS, THE FOLLOWING FIELDS HAVE NOW BEEN UPDATED: B1 - ADVERSE EVENT TICKED. G4 - 510K NUMBER ADDED. H2 - UPDATED AS CORRECTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BLEEDING OCCURING DURING DBS (DEEP BRAIN STIMULATION) SURGERY WHICH LED TO THE PATIENT BEING PLACED IN INTENSIVE CARE POST-OPERATIVELY AND LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573845 LEKSELL STEREOTACTIC SYSTEM - MPS ARC NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW ELEKTA INSTRUMENT AB 1000689 07340048305600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death