BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 17944016 · Received October 16, 2023

    Report

    Report Number
    1723170-2023-01969
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    July 13, 2023
    Report Date
    October 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
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID: 8801071 LOT: 2112181, UDI#: (B)(4); PRODUCT ID: 8801071 LOT: 2112191, UDI#: (B)(4). THIS EVENT WAS ORIGINALLY REPORTED ON THE SPHERES (PRODUCT ID: 8801071) INVOLVED IN THE EVENT. THE EVENT WILL NOW BE REPORTED UNDER THE SYSTEM INVOLVED IN THE EVENT. THE SPHERES ARE ASSOCIATED PRODUCTS. PLEASE REFERENCE REGULATORY REPORT NUMBERS: 1723170-2023-01252 AND 1723170-2023-01262. ANY FURTHER SUPPLEMENTAL REPORTS WILL BE REPORTED UNDER THIS REGULATORY REPORT. H3, H6: NO PRODUCTS WERE RECEIVED BY THE MANUFACTURER FOR ANALYSIS. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE USED THE BAGS OF SPHERES TO CLEAR STOCK FOR NAVIGATION. THE NAVIGATION DID NOT RECOGNIZE THE INSTRUMENTS. AN INACCURACY OCCURRED. THERE WAS AN INCREASED INTERVENTION TIME TO FIND AND REMEDY THE PROBLEM. THE USE OF NAVIGATION WAS ABORTED. THE SURGERY WAS DISCONTINUED. DELAY IN SURGERY AND PATIENT IMPACT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332494 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other