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

Model Number FUSION

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

On 11/14/2016 a medtronic representative, following-up at the site, reported the surgeon operated on the patient, with the exception of not completing the frontal sinuses.Pre-op, the surgeon stated not being confident performing the frontal procedure without navigation.- no parts have been received by manufacturer for analysis.- no further issues have been reported.Part not received by manufacturer.

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the site failed tracer registration 7-8 times.They also attempted pointmerge registration and were unsuccessful.The surgeon was using a stingray tracker.The medtronic representative recommended using a 3 point tracer.The surgeon opted to discontinue the use of the navigation system to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment and replaced the system monitor for an unrelated issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Manufacturer Narrative

Device manufacture date provided.

• Brand Name: FUSION NAVIGATION 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6133936
• MDR Text Key: 61096233
• Report Number: 1723170-2016-05476
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• 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,Followup,Followup
• Report Date: 02/15/2017

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
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2016; 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2011
• 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: 43 YR
• Patient Weight: 113