MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PLANNING STATION; INSTRUMENT, STEREOTAXIC

Model Number	9735894
Medical Device Problem Codes	Failure to Shut Off (2939); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the ssd for the system was replaced.The system then passed the system checkout and was found to be fully functional.Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: 9 735999, serial/lot #: unk, ubd: , udi#:.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the navigation system would intermittently not boot.Additionally, it was noted that the system would not power down as an unspecified function would not halt and required a hard shut down with the power button.Troubleshooting was noted to have replaced the ssd to restore functionality and the issue was caused by the ssd.There was no patient present when this issue was identified.

• Brand Name: STEALTHSTATION S8 PLANNING STATION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11701559
• Report Number: 1723170-2021-01071
• Device Sequence Number: 3722293
• Product Code: HAW
• UDI-Device Identifier: 00643169946538
• UDI-Public: 00643169946538
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735894
• Device Catalogue Number: 9735894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1