BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 18588834 · Received January 26, 2024

    Report

    Report Number
    1723170-2024-00350
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 15, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE SYSTEM WAS SERVICED IN THE FIELD AND THE SYSTEM SHUT DOWN AFTER BEING PLUGGED INTO AN OUTLET THAT LOST POWER. THE BATTERIES, UPS, AND FUSES WERE REPLACED. CODES B01, C02, D02 ARE APPLICABLE TO THIS ANALYSIS. D9, H2, H3: THE RETURN OF 9735773 PROVIDED THE LOT NUMBER 2204. THE HARDWARE WAS RETURNED AND ANALYSIS WAS PERFORMED. THE BATTERY WAS TESTED (50.18V) WITH A KNOWN GOOD THE UPS FOR A 24HR PERIOD. THE UPS WAS THEN UNPLUGGED FROM AC POWER AND DID SHUT DOWN IMMEDIATELY. THE BATTERY DID SHOW SIGNS OF LEAKAGE AND DID TEST FOR HAVING DEAD CELLS. CODES B01, C02, D02 ARE APPLICABLE TO THIS ANALYSIS. THE RETURN OF 9735787 PROVIDED THE LOT NUMBER 22160043. THE HARDWARE WAS RETURNED AND ANALYSIS WAS PERFORMED. THE UPS WAS TESTED WITH KNOWN GOOD EQUIPMENT AND WAS UNABLE TO POWER ON. CODES B01, C02, D02 ARE APPLICABLE TO THIS ANALYSIS. THE RETURN OF 9735784 PROVIDED THE LOT NUMBER 190326. THE HARDWARE WAS RETURNED AND ANALYSIS WAS PERFORMED. THE RETURNED CABLE HAS NO PHYSICAL DAMAGE AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. CODES B01, C19, D14 ARE APPLICABLE TO THIS 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. 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

    BRAND NAME ; PRODUCT ID 9735773 (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM BRAND NAME ; PRODUCT ID 9735787 (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM BRAND NAME ; PRODUCT ID 9735784 (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE BEING PREPARED FOR USE IN A CASE THE SYSTEM SUDDENLY POWERED DOWN UNEXPECTEDLY AND SITE WAS UNABLE TO POWER IT BACK ON. NO PATIENT WAS PRESENT. ADDITIONAL INFORMATION WAS LATER RECEIVED. A MEDTRONIC REPRESENTATIVE (REP) CALLED TO REPORT THAT THE SYSTEM HAD BEEN STORED PLUGGED INTO AN OUTLET IN A STORAGE ROOM THAT WAS LATER FOUND TO BE POWERED OFF. THE SITE HAD SINCE PLUGGED THE SYSTEM INTO A KNOWN WORKING OUTLET AND WAS STILL UNABLE TO TURN ON THE SYSTEM. THE REP COULD NOT HEAR ANY NOISE COMING FROM THE SYSTEM. NO LIGHTS ILLUMINATED WHEN THE POWER BUTTON WAS PRESSED. A CONFIRMED WORKING SYSTEM POWERED ON WITHOUT ISSUE ON THE SAME OUTLET. THE REP CONNECTED A "GOOD" AC CABLE AND GROUNDING WIRE TO THE "BAD" UPS, CONNECTED A "GOOD" SYSTEM TO WALL POWER, AND ATTEMPTED TO TURN ON THE "BAD" SYSTEM. THE SYSTEM DID NOT TURN ON, AND NO FANS WERE HEARD ON THE UPS AND NO LIGHTS COULD BE SEEN. THEY CONNECTED A "BAD" AC CABLE AND GRO UNDING WIRE TO THE "GOOD" UPS, CONNECTED THE "BAD" SYSTEM TO WALL POWER, ATTEMPTED TO TURN ON THE "GOOD" SYSTEM. THE SYSTEM DID NOT TURN ON, AND NO FANS WERE HEARD ON THE UPS AND NO LIGHTS COULD BE SEEN. THE REP REPORTED THE GROUNDING CABLE WAS NOT TIGHTENED ALL THE WAY DOWN DURING TESTING. THEY TIGHTENED AND ATTEMPTED TO TURN ON SYSTEM AGAIN TO NO EFFECT. DURING TROUBLESHOOTING, THE REP DETECTED V6 CONNECTION WAS LOOSE ON "BAD" SYSTEM. THEY RE-SEATED CABLE THE CABLE. THEY RETURNED ALL COMPONENTS TO THEIR ORIGINAL SYSTEMS AND TURNED ON "GOOD" SYSTEM. THE SYSTEM TURNED ON WITHOUT ISSUE. THEY REMOVED THE BATTERY FROM THE "BAD" SYSTEM, AND THE BOTTOM OF THE BATTERY PACK HAD SLIGHT VISIBLE LEAKAGE. THEY CONNECTED A "BAD" EXTERNAL POWER CABLE TO THE "GOOD" SYSTEM, AND THE "GOOD" SYSTEM WAS ABLE TO POWER UP WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316613 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10...