MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733560

Device Problem Human-Device Interface Problem (2949)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in a functional endoscopic sinus surgery (fess), an imprecision was observed following patient registration and subsequently elected to discontinue with the procedure.It was reported that there were six computed tomography (ct) exams for the patient.It was noted that the site did not select the proper grouping of three exams that included an axial exam with appropriate slice thickness.It was reported the site used a coronal exam with a lower slice count and 2-3millimeter slick thickness.Following the procedure, a separate procedure with the same navigation system was performed on a separate patient without issue.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.

Manufacturer Narrative

The total inaccuracy of the event was 5 mm.A review of the archives found no registrations present on archive.Two of the exams were axial and to protocol.There was also a coronal and sagittal, both with top, sides, and back of the head cut off.All exams loaded 3d models as blocks.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Software analysis was initiated to determine the cause of the issue.It was confirmed that the behavior described is the intended behavior of the software.Software is functioning as designed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8172053
• MDR Text Key: 130616016
• Report Number: 1723170-2018-06325
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169504394
• UDI-Public: 00643169504394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560
• Device Catalogue Number: 9733560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 92