MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	S7
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi number was incorrect on the original file.Manufacturing date was received.
Additional Manufacturer Narrative
Manufacturing date unavailable at the time of filing.Onsite functional and visual examination was performed by a manufacturer representative.The issue was resolved after parts were replaced.The system passed a system checkout and the system was returned to an operational condition.The computer was returned for analysis.Analysis consisted of functional testing.No issue was found with the returned device.
Event or Problem Description
Medtronic received information regarding an imaging device being used for a sacroiliac and thoracolumbar procedure.It was reported that when the site was getting ready to spin they were not getting communication.Looking at the navigation, the mouse was unresponsive.They hard booted the system, but then it would not boot up and was displaying no input detected.They tried to boot a few times to no avail.Listening to the computer, the fan on it was cycling.Medtronic navigation was aborted.There was a reported delay of less than one hour and no reported impact to patient outcome.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7694979
• Report Number: 1723170-2018-03510
• Device Sequence Number: 11011921
• Product Code: HAW
• UDI-Device Identifier: 00613994806604
• UDI-Public: 00613994806604
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2018

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: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 07/17/2018; 08/15/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 07/17/2018; 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 116