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

Model Number	9734062
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/12/2019
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 manufacturer representative (rep) regarding a navigation system outside of a procedure.The rep indicated that the camera fault light was flashing and the system displayed localizer disconnected.The site continued the case with a different system and no patient was present at the time of the issue.The rep continued troubleshooting and when the ndi toolbox was checked and it was unable to connect to the psu.The rep pushed the restart switch on the back of the niu with no change and the usb view was check and the i/o hub was found to be missing.On the transceiver in the rack the power lights were missing on the opt link and the usb link.When the rep was moving the rack to open the side panel they saw disconnected cables.The rep was unsure if the accidentally disconnected the cables during the move or if they were already disconnected.The rep later tried changing the camera from the system to another system and the new system also did not function suggesting the issue was with the camera so a new camera was shipped.
Additional Manufacturer Narrative
Additional information: the psu was returned to the manufacturer for analysis.Analysis found that the psu powered on with amber fault light on.A check of the event logs indicated low battery voltage for the bump detector battery.Otherwise, psu passed accuracy test.Analysis found that the reported event was related to a electrical issue.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that there was a red error led illuminated on the camera, broken fiber optic cables, and a damaged transceiver.The camera was replaced and the issues resolved, but then there was no communication with the new camera.It was discovered the firmware of the camera and the scu did not match.The firmware was updated.The system then passed the system checkout and 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 from a manufacturer representative (rep) regarding a navigation system outside of a procedure.The rep indicated that the camera fault light was flashing and the system displayed localizer disconnected.The site continued the case with a different system and no patient was present at the time of the issue.The rep continued troubleshooting and when the ndi toolbox was checked and it was unable to connect to the psu.The rep pushed the restart switch on the back of the niu with no change and the usb view was check and the i/o hub was found to be missing.On the transceiver in the rack the power lights were missing on the opt link and the usb link.When the rep was moving the rack to open the side panel they saw disconnected cables.The rep was unsure if the accidentally disconnected the cables during the move or if they were already disconnected.The rep later tried changing the camera from the system to another system and the new system also did not function suggesting the issue was with the camera so a new camera was shipped.

• 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: 8533011
• Report Number: 1723170-2019-01868
• Device Sequence Number: 16469659
• Product Code: HAW
• UDI-Device Identifier: 00613994665928
• UDI-Public: 00613994665928
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 9734062
• Device Catalogue Number: 9734062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 05/01/2019; 06/13/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/17/2019; 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1