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

Model Number	9733856R
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturer representative went to the site to test the equipment.It was reported that the system had too many scans loaded and the system's available space was at zero so the system would not allow any more downloads.The storage space was cleaned.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system during a functional endoscopic sinus surgery (fess).It was reported that the disc was loaded and the site saw the study was a name on the right-hand side of the import screen.The site selected "download all" and the series displayed "green checks" on the right-hand side but there was no name of the patient.The site was unable to see the downloaded patient on the patient screen.The site organized by data and attempted to reload the patient again but never saw the patient.The use of navigation was aborted.There was no patient impact and the surgery was completed with an hour delay.

• Brand Name: STEALTHSTATION® S7® SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7945075
• Report Number: 1723170-2018-05017
• Device Sequence Number: 13667228
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 MO
• Patient Weight: 8