MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 NAVIGATION; INSTRUMENT, STEREOTAXIC

Model Number	9734894
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9735225, serial/lot #: (b)(4), ubd: unk, udi#: unk.A medtronic representative went to the site to test the equipment.Testing revealed that hardware parts were replaced.The imaging system then passed the system checkout and was found to be fully functional.The computer was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.No failure was found with the returned computer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that when the system is powered on, the monitor shows "no signal" and the camera does not beep.The fan can be heard cycling.There was no patient involvement.

• Brand Name: STEALTHSTATION S7 NAVIGATION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11543931
• Report Number: 1723170-2021-00750
• Device Sequence Number: 4091109
• Product Code: HAW
• UDI-Device Identifier: 00643169105232
• UDI-Public: 00643169105232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 9734894
• Device Catalogue Number: 9734894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1