MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7´; INSTRUMENT, STEREOTAXIC

Model Number	9733857
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9733625, serial/lot #: (b)(4).A medtronic representative (rep) went to the site to test and service the equipment.The rep stated the reported symptom occurred randomly, but that it may have been related to a uninterruptible power supply (ups) problem.The rep decided to replace the ups with a new one.The navigation system passed the system checkout and was found to be fully functional.Device manufacturing date 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.It was reported that intermittently the system shut down when the customer used the axiem system and optical camera.It was stated that the system was plugged in to a known functional electrical outlet when the system shut down.There was no patient involvement.

• Brand Name: STEALTHSTATION® S7´
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8825875
• Report Number: 1723170-2019-04220
• Device Sequence Number: 2337159
• Product Code: HAW
• UDI-Device Identifier: 00613994450951
• UDI-Public: 00613994450951
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/25/2019

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: 9733857
• Device Catalogue Number: 9733857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1