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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier field not sufficient to hold all digits, should read: (b)(6).On 11/22/2016 a medtronic representative noted an attempt to verify navigation system accuracy during an accuracy check, however, did not feel that the unit was accurate.The medtronic representative performed a navigation system check-out, all areas passed.System performed as intended on 11/29/2016 software investigation completed.Findings are that the patient has soft skin and does not appear to be an ideal candidate for tracer.The tracer pattern did not appear posterior and lateral patient anatomy.Software is functioning as designed.- no further issues have been reported.
Event or Problem Description
A medtronic representative reported that, while in a cranial resection procedure, the surgeon alleged an inaccuracy occurred.The inaccuracy was alleged to be 1 centimeter posterior within mach cranial software and was noted once the patient was sterile.The medtronic representative noted the patient had loose skin and the skin was manipulated on 3d model from headphones during mr.Surgical entry point was near ear.No further details regarding this issue were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
Additional Manufacturer Narrative
The instructions for use (ifu) that accompanies the device provides guidance for multiple registration methods.
Additional Manufacturer Narrative
Device manufacture date updated.

• 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: 6145741
• Report Number: 1723170-2016-05630
• Device Sequence Number: 368402
• 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,Followup,Followup
• Report Date (Section B): 02/28/2017

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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 12/29/2016; 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 100