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

Model Number FUSION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2012

Event Type  Injury  

Event Description

A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess) procedure, the surgeon noted that when putting the probe into the ethmoid sinus the software showed it being 2cm below the ethmoid skull base.This was tested in numerous other locations, superficially and internally, on known brain locations and showed accurate each time.A neurosurgeon joined the procedure and determined that the patient's anatomy was likely abnormal from previous surgeries and had a possible hemorrhage or cephalacy.The surgeons chose to discontinue the procedure based on this new information regarding patient anatomy and would request another mri be done.There was no impact on patient outcome.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's fusion navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

This event is being reported as a result of a retrospective review of similarly reported events that were initially deemed not-reportable to the fda.The aware date of the need to perform this retrospective review is correctly documented as (b)(4) 2013.A medtronic representative, following-up, reported the patient did get another mri; results were not available.No surgery had been rescheduled.The navigation system was used successfully since this event and performed well.Software investigation completed, conclusion is that the issue was a result of abnormal patient anatomy.Due to the anatomy shifting, this caused the reported issue.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's fusion navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 3554858
• MDR Text Key: 4214922
• Report Number: 1723170-2014-00007
• Device Sequence Number: 1
• Product Code: HAW
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2010
• 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: 58 YR
• Patient Weight: 66