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

Model Number	9733560XOMR
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts were returned to the manufacturer 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 device being used for a functional endoscopic sinus surgery (fess).It was reported that the surgeon was unable to register the patient.The tracker cad model was showing as the old style tracker and then disappeared.The trace points were collecting off the 3d model.The site aborted navigation.There was a reported delay of less than one hour and no reported impact to patient outcome.
Additional Manufacturer Narrative
A software investigation was initiated.It was determined that based on the reported information the software investigation was inconclusive.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IGS ENT SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9081718
• Report Number: 1723170-2019-04924
• Device Sequence Number: 2837626
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• 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
• Report Date (Section B): 10/17/2019

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: 9733560XOMR
• Device Catalogue Number: 9733560XOMR
• Device Lot Number: N04087076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1