BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7¿

    MDR report key: 17345040 · Received July 18, 2023

    Report

    Report Number
    1723170-2023-01269
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 18, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE ACCEPTED DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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. 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

    AIBAR-DURAN, J.A., COLLADO, I.C., BEJARANO, A.R., NEVADO, R.S., BOLANOS, I.A., GARCFA-COMET, J., ALONSO-SOLFS, A., BELLO, E.M.G., QUINTANA SCHMIDT, C., HERNANDEZ, F.M., TEIXIDO, J.M., RODRIGUEZ. R.R. LONG-TERM OUTCOMES OF DEEP BRAIN STIMULATION FOR TREATMENT-RESISTANT SCHIZOPHRENIA: EXPLORING POTENTIAL TARGETS. JOURNAL OF PSYCHIATRIC RESEARCH. 2023. 163 (296-304) HTTPS://DOI.ORG/10.1016/J.JPSY CHIRES.2023.05.056 ABSTRACT: BACKGROUND: SCHIZOPHRENIA IS A COMPLEX AND DISABLING DISORDER. AROUND 30% OF PATIENTS HAVE TREATMENT-RESISTANT SCHIZOPHRENIA (TRS). OBJECTIVE: THIS STUDY SUMMARIZES THE OUTCOMES AFTER THREE YEARS FOLLOW-UP OF THE FIRST SERIES OF PATIENTS WITH TRS TREATED WITH DEEP BRAIN STIMULATION (DBS) AND DISCUSS SURGICAL, CLINICAL AND IMAGING ANALYSIS. METHODS: EIGHT PATIENTS WITH TRS TREATED WITH DBS IN THE NUCLEUS ACCUMBENS (NACC) OR THE SUBGENUAL CINGULATE GYRUS (SCG) WERE INCLUDED. SYMPTOMS WERE RATED WITH THE PANSS SCALE AND NORMALIZED USING THE ILLNESS DENSITY INDEX (IDI). A REDUCTION IN IDI-PANSS OF 2:25% COMPARED TO BASELINE WAS THE CRITERION OF GOOD RESPONSE. THE VOLUME OF ACTIVATED TISSUE WAS CALCULATED TO PERFORM A CONNECTOMIC ANALYSIS FOR EACH PATIENT. AN ESTIMATION OF THE TRACTS AND CORTICAL AREAS MODULATED WAS GENERATED. RESULTS: FIVE WOMEN AND THREE MEN WERE ANALYZED. AFTER 3 YEARS' FOLLOW-UP, POSITIVE SYMPTOMS IMPROVED IN 50% OF THE SCG GROUP AND 75% OF THE NACC GROUP (P = 0.06), AND GENERAL SYMPTOMS IMPROVED IN 25% AND 50% RESPECTIVELY (P = 0.06). THE SCG GROUP SHOWED ACTIVATION OF THE CINGULATE BUNDLE AND MODULATION OF ORBITO­FRONTAL AND FRONTOMESIAL REGIONS; IN CONTRAST, THE NACC GROUP SHOWED ACTIVATION OF THE VENTRAL TEGMENTAL AREA PROJECTIONS PATHWAY AND MODULATION OF REGIONS ASSOCIATED WITH THE "DEFAULT MODE NETWORK" (PRECUNEUS) AND BRODMANN AREAS 19 AND 20. CONCLUSIONS: THESE RESULTS SHOWED A TREND TOWARD IMPROVEMENT FOR POSITIVE AND GENERAL SYMPTOMS IN PATIENTS WITH TRS TREATED WITH DBS. THE CONNECTOMIC ANALYSIS WILL HELP US UNDERSTAND THE INTERACTION OF THIS TREATMENT WITH THE DISEASE TO PURSUE FUTURE TRIAL DESIGNS. REPORTABLE EVENTS: ALL LEADS WERE SATISFACTORY PLACED BUT ONE (IN THE NACC GROUP) WHICH WAS LOCATED POSTERIOR AND DORSAL TO THE VENTRAL STRIATUM (RATHER PLACED IN THE ANTERIOR LIMB OF THE INTERNAL CAPSULE, ALIC) HOW­EVER THE PATIENT REFUSED TO BE RE-OPERATED. PLEASE SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170273 STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female