MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number	9735602
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing date was unavailable at the time of filing.No part have been returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that the site was unable to get passing registration on the system.Registration was attempted numerous times, but the points looked to be collecting under the skin.Thresholding the model did not help and the health care profession decided to abort the use of navigation.There was less than an hour delay in the procedure.No impact on patient outcome.Additional information was received: the representative was on the site for a clinical case.There was no issue during the clinical case.The site used the scanner they used for the first case for the second case.The rep noticed that the default import threshold was 388, although the 3d model looked good, the model building view showed that there was slight "fuzziness" at the edges of the 2d exams that were included in the model.When the representative adjusted the threshold to 720, the 3d model still looked great, but the fuzziness at the edges of the 2d view were not included.The surgeon used this for the clinical and got a passing registration on the first try, at the end of the case the rep asked the surgeon to try and register the exam while it was set to its original threshold value.The surgeon was unable to get a passing registration of the scan.
Additional Manufacturer Narrative
A software analysis was initiated.Analysis determined that the software was functioning as designed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received: engineering noted that there is no way to specify the default threshold for 3d models in the software.

• Brand Name: FUSION COMPACT
• Common Device Name: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8428643
• Report Number: 1723170-2019-01161
• Device Sequence Number: 1288708
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2019

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: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 04/22/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/19/2019; 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 120