MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC I7; INSTRUMENT, STEREOTAXIC

Model Number	9734061
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Report source foreign country: (b)(6).The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and the fuse was replaced.After the replacement the issue was resolved.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 has done some tests on site and the positioning sensor unit (psu) completely stopped working.It was blacked out and no leds were visible while the system was turned on.The navigation interface unit (niu) was working however and the monitors were also functional.No patient was present at the time of the event.Additional information was received stating that the root cause of this error was a broken microfuse of the remote control unit (rcu) spectra unit.

• Brand Name: I7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9740919
• Report Number: 1723170-2020-00602
• Device Sequence Number: 1802259
• Product Code: HAW
• UDI-Device Identifier: 00613994667458
• UDI-Public: 00613994667458
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 9734061
• Device Catalogue Number: 9734061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1