STEALTHSTATION¿ S8 SYSTEM
Report
- Report Number
- 1723170-2025-02322
- Event Type
- Malfunction
- Date Received
- June 13, 2025
- Date of Event
- June 2, 2025
- Report Date
- July 1, 2025
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- HAW
- UDI-DI
- 00763000272739
- PMA / PMN Number
- K162309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821R: PRODUCT ID: 9735821R: H3: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT HARDWARE PARTS WERE REPLACED. THE NAVIGATION SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. H6: B17, C20 AND D15 APPLY TO THE CONCOMITANT PRODUCTS. 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, H3, H6) THE 9735821R CAMERAS (LOT NUMBERS: P903400 & P904329) WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED POSITIONING SENSOR UNITS (PSU) HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .637MM WITH A PASSING THRESHOLD OF .250MM. THE SECOND PSU WAS RETURNED IN A BOX THAT HAD BEEN DAMAGED WITH ONE END NEARLY TORN OFF. LIKEWISE, A CHECK OF THE EVENT LOG SHOWED A DETECTED BUMP. NO PHYSICAL DAMAGE WAS OBSERVED. OTHERWISE, THE PSU PASSED AN ACCURACY TEST (AAK) AT .101MM WITH A PASSING THRESHOLD OF .250MM. THE BUMP SENSOR WAS CLEARED AND THE PSU IS NOW FULLY FUNCTIONAL. CODE C08 IS APPLICABLE. 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.
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING "LOCALIZER FAULTED." IT WAS DISCOVERED BEFORE A CASE AND THE SITE WAS ABLE TO SWAP TO THEIR OTHER SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. IT WAS NOTED THAT AFTER INSTALLING A NEW CAMERA, THE ERROR STILL OCCURRED. THE CAMERA FAILED FROM THE CMOS BATTERY ERROR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT A MANUFACTURER REPRESENTATIVE (REP) TRIED TO RESTART THE SYSTEM AND RECONNECTED THE CARTS 3 TIMES WITH NO RESOLUTION. THE REP PLANNED TO USE ANOTHER SYSTEM TO BYPASS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 570136 | STEALTHSTATION¿ S8 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC | 9735665 | 00763000272739 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |