MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC EQUIPMENT RACK 9734061 I7 220V; INSTRUMENT, STEREOTAXIC

Model Number	9734061
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient demographics refused by the site.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 that the customer is complaining about the fact that after each imaging scan, when everything is switch on again, the microscope (does not matter what scope it is - leica or pentero) and the navigation system do not communicate anymore.This results in scope-navigation is not available immediately after the imaging scan.A restart of the navigation computer solves the situation.But this could not be the solution the equipment was designed for.The issue was identified during a cranial resection procedure.There was no delay to the procedure, and no reported impact on patient outcome.
Additional Manufacturer Narrative
Other relevant device(s) are: software: mach polestar treon; s7;i7; polestar int sys 5.3.1 9734220 software version: 5.3.1.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The system was serviced in the field and passed all tests.No failures were found and the system was performing as intended.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The software analysis was unable to determine probable cause without further information since the behavior cannot be replicated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EQUIPMENT RACK 9734061 I7 220V
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9415277
• Report Number: 1723170-2019-05867
• Device Sequence Number: 16750156
• Product Code: HAW
• UDI-Device Identifier: 00613994667458
• UDI-Public: 00613994667458
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2020

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: 9734061
• Device Catalogue Number: 9734061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 12/05/2019; 01/30/2020; 03/19/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/27/2019; 02/24/2020; 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1