MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UPGRADE PRGM 9734261 STEALTHSTATION S7; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	S7
Medical Device Problem Codes	Use of Device Problem (1670); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware and software passed the system checkout.The system was found to be fully functional.No parts were replaced or returned.
Event or Problem Description
A medtronic representative reported that prior to a visualase procedure, the surgeon monitor on the navigation system began flickering.The system was on for a few hours when the issue began.The cable connections were checked and the monitor was reseated to the main cart connection with no change.The case was continued with the flickering monitor.There was no reported delay to the procedure due to this issue or impact on patient outcome.

• Brand Name: UPGRADE PRGM 9734261 STEALTHSTATION S7
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6742481
• Report Number: 1723170-2017-03040
• Device Sequence Number: 10895573
• Product Code: HAW
• UDI-Device Identifier: 00643169510531
• UDI-Public: 00643169510531
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734261
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 94