MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	I7
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.A medtronic representative inspected the navigation system onsite and confirmed the issue.The representative was able to identify the touch panel input (input #2) on the transceiver was related to the monitor presenting the problem.The transceiver touch panel input #2 had a fiber optic cable labeled channel 1 connected and the monitor the fiber optic cable connected was labeled #2.The issue was resolved by changing the fiber optic cable at the monitor to channel #1.No parts required replacement.No parts were returned to the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that while in a procedure the touch screen monitor on the navigation system showed "searching for dvi connection".The monitor is not functioning.The site used the other monitors and proceeded with the case.There was no delay to the procedure as a result of this issue and no impact on the patient outcome.
Additional Manufacturer Narrative
Additional information: patient demographics provided.A medtronic representative reported that the issue occurred in an oblique lumbar interbody fusion (olif).
Additional Manufacturer Narrative
Device code was corrected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7172031
• Report Number: 1723170-2018-00094
• Device Sequence Number: 13677091
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,other
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2019

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: Physician
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/16/2018; 05/08/2019
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 02/06/2018; 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 73