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

Model Number	ENAV
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned to the manufacturer for analysis.Part not returned.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a cranial resection procedure.It was reported that the cranial frame and passive planar blunt instruments were flickering continuously.The surgeon was able to register the patient, but the flickering continued.Tracking view showed the camera was positioned too close in the field of view.The site re-positioned the camera, but this did not resolve the issue.Changing out spheres did not help.The site covered up each cranial frame sphere and discovered one that when covered helped the flickering a little bit.It was recommended that the site replace the sphere or not use that particular sphere on the frame.Removing the sphere did not help and the instrument and frame continued to flicker.They put a new sphere on the frame and the system still flickered.Towards the end of the case the camera continued to track without flickering.Delay to surgery 15 minutes.No patient impact.
Additional Manufacturer Narrative
The positioning sensor unit (psu) and navigation system were received by the manufacturer.However, results are not available at this time.

• 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: 7731747
• Report Number: 1723170-2018-03743
• Device Sequence Number: 1405626
• Product Code: HAW
• UDI-Device Identifier: 00613994386021
• UDI-Public: 00613994386021
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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: Health Professional
• Device Model Number: ENAV
• Device Catalogue Number: 9733658
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 136