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

Model Number	ENAV
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Injury (2348); Iatrogenic Source (2498)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier field not sufficient to hold all digits, should read: (b)(4).Medtronic representative at the site, used a demo head and confirmed the navigation system was accurate and functional.Confirmed the articulating arm was tight and there should not have been any frame movement.Surgeon commented he did not really like the inav screen and could not see some things.On (b)(6) 2017 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On ( b)(6) 2017 software analysis was unable to determine probable cause with the information provided.Reported issue could not be replicated.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.
Event or Problem Description
A medtronic representative reported that, while in a cranial procedure, the surgeon alleged an inaccuracy occurred.The surgeon alleged the inaccuracy was approximately 3 centimeters, occurring when creating a posterior bone flap.The physician assistant (pa) performed two tracer registrations and they were happy with the second result.When navigating to the posterior tumor, a bone flap was made, however, then they could not access the posterior part of the tumor so the flap was enlarged and the surgeon alleged a navigation inaccuracy.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.

• 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: 6564247
• Report Number: 1723170-2017-01987
• Device Sequence Number: 16303901
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: ENAV
• Device Catalogue Number: 9733658
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 46