STEALTHSTATION¿ S8 SYSTEM
Report
- Report Number
- 1723170-2024-01075
- Event Type
- Injury
- Date Received
- April 15, 2024
- Date of Event
- April 11, 2024
- Report Date
- October 24, 2024
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- HAW
- UDI-DI
- 00643169722187
- PMA / PMN Number
- K162309
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H2) CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735762, VERSION #: 2.1.0. 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.
H3) THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS RETURNED FOR ANALYSIS. FUNCTIONAL TESTING DETERMINED THAT THE SCU WAS MALFUNCTIONING CAUSING THE REPORTED 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: PRODUCT ID: 9735670 (SERIAL: (B)(6). SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID: 9735821; H3, H6) NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. APPLICABLE CODES: B17, C20, D15. 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: 9735737, VERSION #: 2.0.1. A MANUFACTURER REPRESENTATIVE (REP) WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. THE CAMERA WAS REPLACED AND THE SYSTEM PERFORMED AS INTENDED. CODES: B01, C07, D02 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.
H3) A SOFTWARE ANALYSIS WAS PERFORMED. THERE WAS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE 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.
MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED A LOCALIZER FAULTED MESSAGE WHILE SETTING UP FOR A CASE. THE SITE ELECTED TO PROCEED USING THE EM FUNCTION WITHIN THE SOFTWARE. NAVIGATION APPEARED ACCURATE ON THE RIGHT SIDE OF THE HEAD, BUT APPEARED INACCURATE BY SEVERAL MM ON THE LEFT SIDE NEAR WHERE THE TUMOR WAS WITHIN THE SCAN. ANOTHER NAVIGATION SYSTEM WAS BROUGHT ON SITE. NAVIGATION AND THE SURGERY WAS ABORTED. THE SURGERY WAS RESCHEDULED.
ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE BEING PERFORMED WAS A BRAIN TUMOR BIOPSY, THERE WAS A SURGICAL DELAY OF ONE HOUR, THERE WAS NO IMPACT ON PATIENT OUTCOME, AND THE AMOUNT OF THE INACCURACY WAS 1 CENTIMETER ON THE LEFT EAR AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 750759 | STEALTHSTATION¿ S8 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC | 9735665 | 00643169722187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | SEE H11... |