MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9734061
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9733763, version: 2.2.6.A medtronic representative went to the site to test the equipment.It was confirmed a "error connection" occurred when trying to download some series of a patient.The system did not pass the system checkout and further service was pending.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while outside of a procedure, some data series could not be downloaded onto the navigation system.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
A software analysis was initiated as part of the investigation.Analysis found that the reported behavior was the intended functionality of the software.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.It was reported that the probable cause of the issue is due to compressed studies being sent and the software is not able to open compressed studies.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9317858
• Report Number: 1723170-2019-05604
• Device Sequence Number: 10860419
• Product Code: HAW
• UDI-Device Identifier: 00613994667458
• UDI-Public: 00613994667458
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2020

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: 10/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 04/06/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/07/2020; 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1