STEALTHSTATION¿ S8 SYSTEM
Report
- Report Number
- 1723170-2024-02308
- Event Type
- Death
- Date Received
- August 22, 2024
- Date of Event
- March 14, 2024
- Report Date
- August 7, 2025
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- UDI-DI
- 00643169838895
- PMA / PMN Number
- K162309
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H2: ADDITIONAL INFORMATION 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.
H2-3) THE SOFTWARE ANALYSIS CONCLUDED THAT THERE WAS INSUFFICIENT INFORMATION TO DETERMINE IF A SOFTWARE ANOMALY CAUSED THE REPORTED EVENT. THE LOGS WERE ANALYZED AND IT WAS OBSERVED THAT THERE WERE ONLY 2 SESSIONS LOGS AVAILABLE OUT OF WHICH IN ONE THERE WASN'T MUCH ACTIVITY. USER WENT TO IMAGES TASK AND THEN SESSION ENDED. IN THE OTHER SESSION THERE WERE 4 EXAMS THAT WERE IMPORTED FROM MEDIA AND OUT OF WHICH ONE IMPORT FAILED BECAUSE SLICE SPACING WAS NEAR ZERO. THERE WAS MERGE STATE OR PLAN INFORMATION FROM THE LOGS. ALSO FROM THE LOGS IT WAS SEEN THAT THERE WERE MULTIPLE REGISTRATIONS PERFORMED WITH ERROR METRIC RANGING FROM 9 TO 1.9 MILLIMETERS (MM) AND IN THE SESSION SHARED USER NEVER ENTERED INTO NAVIGATION. SO, THE INFORMATION RELATED TO TARGET ALIGNMENT ERROR WAS ALSO NOT CAPTURED. FROM THE INFORMATION RECEIVED FROM THE SITE IT WAS OBSERVED THAT THE SCANS USED WERE NOT OPTIMAL FOR STEALTH AND ALSO THEY WERE OLD DIAGNOSTIC SCANS WHICH MIGHT HAVE LED TO THE REPORTED BEHAVIOR. CODES: B01, C19, D15 H2). PLEASE SEE SECTION D9 FOR WHEN THE DEVICE WAS AVAILABLE FOR EVALUATION. 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.
H2, CORRECTION: B5 UPDATED. D3-4 UPDATED. 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.
CONTINUATION OF D10: CONCOMITANT PRODUCT SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 736113, VERSION #: 1.0. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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 INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THEY STRUGGLED WITH OBTAINING A REGISTRATION. EVENTUALLY AFTER MULTIPLE ATTEMPTS, A REGISTRATION WAS OBTAINED THAT THE DOCTOR WAS SATISFIED WITH. THE DOCTOR INFORMED THAT THE ACCURACY WAS OUT. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT INVOLVED IN THIS EVENT DID NOT DIE.
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THERE WAS AN INACCURACY THAT OCCURRED DURING PATIENT REGISTRATION. THE HEALTHCARE PROFESSIONAL (HCP) WAS ABLE TO GET AN ACCEPTABLE REGISTRATION AND THE HCP CONFIRMATION WAS ACHIEVED. THE SURGERY PROCEEDED AS NORMAL. THE CASE WAS SUCCESSFULLY COMPLETED DESPITE INITIAL REGISTRATION CHALLENGES. IT WAS ALSO NOTED THAT A DIFFERENT HCP HAD STATED THAT THEY WERE EXPERIENCING "SIMILAR ISSUES WITH REGISTRATION." NEITHER DELAY NOR PATIENT IMPACT INFORMATION WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO DELAY TO THE PROCEDURE. IT WAS NOTED THAT THE IMAGE QUALITY WAS UNSATISFACTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1256579 | STEALTHSTATION¿ S8 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | 9735665 | 00643169838895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Death | "SEE H11...." |