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

Model Number ENAV

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

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 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.

Manufacturer Narrative

The instructions for use (ifu) that accompanies the device provides guidance for multiple registration methods.

Manufacturer Narrative

Device manufacture date updated.

• Brand Name: STEALTHNAVIGATOR ENAV SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 6145741
• MDR Text Key: 61496381
• Report Number: 1723170-2016-05630
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994386021
• UDI-Public: 00613994386021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ENAV
• Device Catalogue Number: 9733658
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 100