BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 17390532 · Received July 25, 2023

    Report

    Report Number
    1723170-2023-01316
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    April 24, 2023
    Report Date
    August 16, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN JAPAN, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED: ADDED TO AND PRODUCT INFORMATION RECEIVED. CONCOMITANT PRODUCTS INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 29631, LOT/SERIAL #: (B)(6). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: WORLD NEUROSURG. /2023/ 175:E1210-E1219. HTTPS.//DAI. ARG/10. 1016/J. WNEU.2023.04.099 SUMMARY: BACKGROUND: ELECTRODES FOR STEREOTACTIC ELECTROENCEPHALOGRAPHY (SEEG) ARE TYPICALLY FIXED TO THE SKULL WITH ANCHOR BOLTS. WHEN ANCHOR BOLTS ARE UNAVAILABLE, ELECTRODES HAVE TO BE FIXED USING OTHER METHODS, CARRYING THE POSSIBILITY OF ELECTRODE SHIFT. THIS STUDY, THEREFORE, EVALUATED THE CHARACTERISTICS OF ELECTRODE TIP SHIFT DURING SEEG MONITORING IN PATIENTS WITH ELECTRODES FIXED USING THE SUTURE TECHNIQUE. METHODS: WE RETROSPECTIVELY INCLUDED PATIENTS WHO UNDERWENT SEEG IMPLANTATION WITH SUTURE FIXATION AND EVALUATED THE TIP SHIFT DISTANCE (TSO) OF ELECTRODES. POSSIBLE INFLUENCES EVALUATED INCLUDED: 1) IMPLANTATION PERIOD, 2) LOBE OF ENTRY, 3) UNILATERAL OR BILATERAL IMPLANTATION, 4) ELECTRODE LENGTH, 5) SKULL THICKNESS, AND 6) SCALP THICKNESS DIFFERENCE. RESULTS: A TOTAL OF 50 ELECTRODES IN 7 PATIENTS WERE EVALUATED. TSO WAS 1.4 ± 2.0 MM (MEAN ± STANDARD DEVIATION). IMPLANTATION PERIOD WAS 8.1 ± 2.2 DAYS. ENTRY LOBE WAS FRONTAL FOR 28 ELECTRODES AND TEMPORAL FOR 22 ELECTRODES. IMPLANTATION WAS BILATERAL FOR 25 ELECTRODES AND UNILATERAL FOR 25 ELECTRODES. ELECTRODE LENGTH WAS 45.4 ± 14.3 MM. SKULL THICKNESS WAS 6.0 ± 3.7 MM. SCALP THICKNESS DIFFERENCE WAS -1.5 ± 2.1 MM, WHICH WAS FOUND GREATER IN TEMPORAL LOBE ENTRY COMPARED WITH FRONTAL LOBE ENTRY. ACCORDING TO UNIVARIATE ANALYSES, NEITHER IMPLANTATION PERIOD NOR ELECTRODE LENGTH CORRELATED WITH TSO. MULTIVARIATE REGRESSION ANALYSIS SHOWED THAT ONLY GREATER SCALP THICKNESS DIFFERENCE CORRELATED SIGNIFICANTLY WITH GREATER TSO (P = 0.0018). CONCLUSIONS: GREATER SCALP THICKNESS DIFFERENCE CORRELATED WITH GREATER TSO. SURGEONS NEED TO CONSIDER THE DEGREE OF SCALP THICKNESS DIFFERENCE AND ELECTRODE SHIFT WHEN USING SUTURE FIXATION, ESPECIALLY WITH TEMPORAL LOBE ENTRY. REPORTED EVENT(S): 7 PATIENTS WERE OBSERVED IN THIS STUDY, WITH A MEDIAN AGE OF 41+/- 13.2 YEARS. OF THE 51 TOTAL ELECTRODES PLACED, ONE WAS ACCIDENTALLY PULLED OUT BY THE PATIENT. NO SURGICAL INTERVENTION WAS NEEDED FOR THIS PATIENT. OF THE 50 LEFT, 36 ELECTRODES (72.0%) WERE PUSHED IN COMPARED TO THE INITIAL CT AND 14 ELECTRODES (28.0%) WERE PULLED OUT. PATIENT 3 SHOWED NONSURGICAL INTRACEREBRAL HEMORRHAGE ON CT PERFORMED IMMEDIATELY POSTOPERATIVELY, SO WE DID NOT ATTRIBUTE THIS TO THE FIXATION TECHNIQUE. NO PATIENTS SUFFERED FROM CSF LEAKAGE OR SURGICAL SITE INFECTION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED ISSUE WAS NOT RELEVANT TO THE MEDTRONIC PRODUCT. THE REPORTED CAUSE OF THE EVENT HAS NOT BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843127 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H