MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTH S7; INSTRUMENT, STEREOTAXIC

Model Number	9733856R
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2018
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
Medtronic received information from a user facility regarding a navigation system being used for a cranial resection.The caller reported that the operating room staff were observing the monitors on the system and in the operating room flickering.The caller then reported that "they had the operating room monitors slaved out.It displayed a logo and then went black and then came back up functioning as intended." there was a patient present at the time of this issue, but there was no impact to patient outcome and the delay in surgery was less than one hour.
Additional Manufacturer Narrative
Additional information was received: a representative went to the site to check the system.It was confirmed that the issue was not cause by the system but other interference.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTH S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8204337
• Report Number: 1723170-2018-06503
• Device Sequence Number: 1656793
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: No Information
• Device Model Number: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1