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 Patient Involvement (2645)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that an rn archived another copy and it loaded without issue.
Additional Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be operational.Other relevant device(s) are: product id: 960-152, media io fusion; treon;s7;i7 3.16, 960-152, 3.16.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 outside of a procedure.It was reported that the site was loading an exam as an unstructured dicom and it took an extended period of time.When the scan did load the inferior portion of the scan did not load from the nasal bone down.The site was able to load the scan successfully on the a different navigation system.
Additional Manufacturer Narrative
The software investigation determined that the exam disc was not burned properly.The software functioning as designed.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: 9317812
• Report Number: 1723170-2019-05603
• Device Sequence Number: 11390444
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2020

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/04/2019; 01/27/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/13/2019; 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1