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

Model Number	9733560XOMR
Medical Device Problem Codes	Mechanical Problem (1384); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: sftwr 960-152 media io.The device was not returned, so no analysis was conducted.Device manufacturing date is unavailable.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) procedure.The issue occurred intraoperatively.It was reported that during the clinical case, the patient exam disc would not load.Using the structured option, it would give the patient's name, but when selecting it to load it provided an error stating it was unable to read the disc.When loading with any of the unstructured options, the system did nothing, even after waiting several minutes.Technical services (ts) had the site representative reboot the system and check the free space on the system, which showed 32% free space.The site rep deleted exams until the system was at 40% free space.Selecting unstructured alternate module generated the message of "unable to interpret header data".The site rep will have a new disc burned with uncompressed dicom.The medtronic representative reported that the surgeon did not inform him of any other issues in the case after reburning, and the site has had no further issues.The surgery was completed with navigation and there was no impact on patient outcome.
Additional Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue.Analysis was unable to determine probable cause without further information since the behavior cannot be replicated.This case may be re-opened if additional information is received.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 was provided that there was limited delay with the procedure going on time as planned.

• 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: 8731137
• Report Number: 1723170-2019-03806
• Device Sequence Number: 11330609
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2019

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: N04058985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 08/01/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/13/2019; 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91