MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION(TM) S7(R); INSTRUMENT, STEREOTAXIC

Model Number	9734048
Medical Device Problem Codes	Computer Software Problem (1112); Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Concomitant medical products: other relevant device(s) are: product id: 9736032, serial/lot #: (b)(4) ; product id: 9735894, serial/lot #: (b)(4), foreign report source: (b)(6).The ssd was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The returned planning station ssd will not proceed past the medtronic logo screen, therefore they were unable to proceed with further analysis.Reported issue confirmed.The planning station was returned to the manufacture for evaluation.After functional testing, performance testing and visual/physical examination the reported issue was not confirmed.The initial power on was successfully booted.Multiple power cycles were successful.Both nic ports were fully functional and the system passed a burnin standard test.No failure found.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.There was no patient involvement.After entering the login and password to the system, the monitor remained stuck at the blue screen with manufacturer logo (splash screen).The issue persisted if the site logged in with the admin login as well.The issue was suspected to be related to hard disk damage.The lot number of the replaced ssd could not be obtained.The most likely cause was not determined.The provided information was confirmed via biomedical technician at the site.

• Brand Name: STEALTHSTATION(TM) S7(R)
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10092807
• Report Number: 1723170-2020-01528
• Device Sequence Number: 3406390
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9734048
• Device Catalogue Number: 9734048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1