MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHNAVIGATOR ENAV SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	ENAV
Medical Device Problem Codes	Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that, while in a cranial biopsy, the navigation system exited the application software without prompt from the user.It was reported that prior to the procedure prep, the navigation system functioned as designed.Prior to the patient being intubated, the application software exited without prompt from the user and the surgeon opted to discontinue with the procedure.No additional information was provided.There was no known impact on patient outcome.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Unrelated to the reported issue, it was noted that the digital intercommunication of medicine (dicom) on the navigation system was updated.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

• Brand Name: STEALTHNAVIGATOR ENAV SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7248794
• Report Number: 1723170-2018-00573
• Device Sequence Number: 158108
• Product Code: HAW
• UDI-Device Identifier: 00613994386021
• UDI-Public: 00613994386021
• 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,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: ENAV
• Device Catalogue Number: 9733658
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1