STEALTHSTATION¿ S8 SYSTEM
Report
- Report Number
- 1723170-2025-03654
- Event Type
- Malfunction
- Date Received
- November 5, 2025
- Date of Event
- September 3, 2025
- Report Date
- November 5, 2025
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- UDI-DI
- 00643169722187
- PMA / PMN Number
- K162309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
H2: SECTION B5 HAS BEEN CORRECTED TO REFLECT THE DESCRIPTION OF THE EVENT. 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: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821R, SERIAL/LOT #: (B)(6), UDI#: (B)(4). H3: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE LOCALIZER WAS FAULTED AND THERE WAS AN OPTICAL COMMUNICATION FAILURE. THE CAMERA WAS REPLACED. H6: CODES B01, C08, AND D02 ARE APPLICABLE TO THE SYSTEM CHECKOUT. HW ANALYSIS: H3: THE CAMERA, LOT NUMBER: P901619, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED POSITIONING SENSOR UNIT (PSU) CONTAINED SCRATCHES ON THE HOUSING <(>&<)> LENSES. A CHECK OF THE EVENT LOG SHOWED A BUMP HAD BEEN DETECTED. OTHERWISE, THE PSU PASSED ACCURACY TEST (AAK) AT .140MM WITH A PASSING THRESHOLD OF .250MM. H6: CODES B01, C02, C08 AND D02 ARE APPLICABLE TO THIS ANALYSIS. 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 SITE REQUESTED A CAMERA REPLACEMENT AS DOCUMENTED ON SEVERAL PREVIOUS CASES. NETWORK DEVICE INTERFACE (NDI) TOOLBOX RESULTS WERE NOT DOCUMENTED. THERE WAS NO PATIENT INVOLVED, AND NO IMPACT. CAMERA WAS NOT BEING UTILIZED IN THE PROCEDURE BUT THE FAILURE WAS STILL NOTED. THE PATIENT WAS IN SURGERY FOR A LEAD PLACEMENT PROCEDURE.
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT ALLISON WADE (CSM) CALLED TO REPORT THE SITE WOULD LIKE A CAMERA REPLACEMENT AS DOCUMENTED ON SEVERAL PREVIOUS CASES. NETWORK DEVICE INTERFACE (NDI) TOOLBOX RESULTS WERE NOT DOCUMENTED. THERE WAS NO PATIENT INVOLVED, AND NO IMPACT. CAMERA WAS NOT BEING UTILIZED IN THE PROCEDURE BUT THE FAILURE WAS STILL NOTED. THE PATIENT WAS IN SURGERY FOR A LEAD PLACEMENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2607070 | STEALTHSTATION¿ S8 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | 9735665 | 00643169722187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |