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

Model Number	9734894
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during a cranial resection procedure.It was reported that the system became unresponsive during a case.The representative did not have any more info as to where they were in the software or any patient information.They were walked through the software and 71% of space was being used.Software functioned normally, but they couldn't find a patient with a registration to go forward to navigate task and did not have tools to test navigation anyway.The was no delay.There was no reported impact to patient outcome.No additional information was provided.
Additional Manufacturer Narrative
No patient was involved with this event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received: the site was contacted for patient information and it was reported that there was no patient involved with this event.
Additional Manufacturer Narrative
A software investigation was initiated; however the site declined system servicing or investigation of the event, therefore unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8584492
• Report Number: 1723170-2019-02187
• Device Sequence Number: 3030740
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2019

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?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 12/09/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 12/12/2019; 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1