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	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Concomitant medical products: other relevant device(s) are: product id: 9734699, serial/lot #: (b)(4).The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and the cd/dvd drive was replaced.Eval code method 10 is associated with this analysis eval code result 114 is associated with this analysis eval code conclusion 4315 is associated with this analysis the cd/dvd drive was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue could not be confirmed.The returned driver was found to be fully functional when connected to a known good computer.The driver was able to load and archive exams without issue.No problem was found.Eval code method 10 is associated with this analysis eval code result 213 is associated with this analysis eval code conclusion 67 is associated with this analysis.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that the manufacturer representative (rep) was able to get discs to load on the fusion compact but the same discs would not load on the fusion.The rep reseated the disc drive which resolved the issue.Technical services shipped a dvd drive as a precaution due to the indeterminacy of the issue.No patient was present at the time of the event.

• 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: 8848146
• Report Number: 1723170-2019-04320
• Device Sequence Number: 2206491
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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: N01700931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1