BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 20027261 · Received August 22, 2024

    Report

    Report Number
    3004785967-2024-00490
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 7, 2024
    Report Date
    September 5, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION WAS ADDED TO B5. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ADVERSE EVENTS REPORTED IN THE ARTICLE AS RELATED TO STIMULATION, DID NOT HAPPEN IN PATIENTS IMPLANTED WITH MEDTRONIC DEVICES.

    Description of Event or Problem · 0

    CITATION: NEUROSURGICAL REVIEW (2024) 47:342 HTTPS://DOI.ORG/10.1007/S10143-024-02563-1 SUMMARY: THE USE OF MICROELECTRODE RECORDING (MER) DURING DEEP BRAIN STIMULATION (DBS) FOR PARKINSON DISEASE IS CONTROVERSIAL. FURTHERMORE, IN ASLEEP DBS ANESTHESIA CAN IMPAIR THE ABILITY TO RECORD SINGLE-CELL ELECTRIC ACTIVITY. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE OUR SURGICAL AND ANESTHESIOLOGIC PROTOCOL FOR MER ASSESSMENT DURING ASLEEP SUBTHALAMIC NUCLEUS (STN) DBS AND TO PUT OUR FINDINGS IN THE CONTEXT OF A SYSTEMATIC REVIEW OF THE LITERATURE. SIXTY-THREE STN ELECTRODES WERE IMPLANTED IN 32 PATIENTS UNDER GENERAL ANESTHESIA. A FRAMELESS TECHNIQUE USING O-ARM SCANNING WAS ADOPTED IN ALL CASES. TOTAL INTRAVENOUS ANESTHESIA, MONITORED WITH BISPECTRAL INDEX, WAS ADMINISTERED USING A TARGET CONTROLLED INFUSION OF BOTH PROPOFOL AND REMIFENTANIL. A SYSTEMATIC REVIEW OF THE LITERATURE WITH METANALYSIS ON MER IN ASLEEP VS AWAKE STN DBS FOR PARKINSON DISEASE WAS PERFORMED. IN OUR SERIES, MER COULD BE RELIABLY RECORDED IN ALL CASES, IMPACTING PROFOUNDLY ON ELECTRODE POSITIONING: THE FINAL POSITION WAS LOCATED WITHIN 2 MM FROM THE PLANNED TARGET ONLY IN 42.9% CASES. DEPTH MODIFICATION > 2 MM WAS NECESSARY IN 21 CASES (33.3%), WHILE IN 15 CASES (23.8%) A DIFFERENT TRACK WAS USED. AT 1-YEAR FOLLOW-UP WE OBSERVED A SIGNIFICANT REDUCTION IN LEDD, UPDRS PART III SCORE OFF-MEDICATIONS, AND UPDRS PART III SCORE ON MEDICATIONS, AS COMPARED TO BASELINE. THE SYSTEMATIC REVIEW OF THE LITERATURE YIELDED 23 PAPERS; ADDING THE CASES HERE REPORTED, OVERALL 1258 ASLEEP DBS CASES USING MER ARE DESCRIBED. THIS TECHNIQUE WAS SAFE AND EFFECTIVE: METANALYSIS SHOWED SIMILAR, IF NOT BETTER, OUTCOME OF ASLEEP VS AWAKE PATIENTS OPERATED USING MER. MER ARE A USEFUL AND RELIABLE TOOL DURING ASLEEP STN DBS, LEADING TO A FINE TUNING OF ELECTRODE POSITION IN THE MAJORITY OF CASES. COLLABORATION BETWEEN NEUROSURGEON, NEUROPHYSIOLOGIST AND NEUROANESTHESIOLOGIST IS CRUCIAL, SINCE SLIGHT MODIFICATIONS OF SEDATION LEVEL CAN IMPACT PROFOUNDLY ON MER RELIABILITY. REPORTED EVENTS: THERE WERE 32 PATIENTS OBSERVED IN THIS STUDY, 18 MALE AND 14 FEMALE. THE MEAN AGE WAS 60.3 YEARS. THERE WAS ONE CASE OF DYSARTHRIA, ONE SEIZURE AFTER THE START OF THE STIMULATION, AND 2 CASES OF DYSTONIA. PER MEDICAL SAFETY REVIEW, IT WAS DETERMINED THAT THE REPORTED EVENTS OF ONE CASE OF DYSARTHRIA, ONE SEIZURE AFTER THE START OF STIMULATION, AND TWO CASES OF DYSTONIA ARE UNRELATED TO THE IMAGING SYSTEM AND ARE KNOWN POTENTIAL SIDE EFFECTS WHEN INITIATING DEEP BRAIN STIMULATION. THE EFFECTS WERE SUCCESSFULLY MANAGED BY ADJUSTING STIMULATION PARAMETERS. THE ARTICLE STATES ¿NO SURGICAL COMPLICATIONS WERE DETECTED¿. THE INFORMATION AVAILABLE INDICATES THE DEVICE PERFORMED AS INTENDED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273626 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| H