MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735665
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9 735836, (cable ethernet kit s8 svc) serial/lot #: unknown, udi#: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a spinal procedure.It was reported that the camera was unable to see any spheres and the o-arm tracker.The representative recommended disconnecting the main cart and camera cart until the network connection lost message appears on the camera cart.At this point the camera cart was re-connected and communication and tracking was reestablished successfully.There was no impact to the patient and delay was less than an hour.Additional information received, it was stated that in troubleshoot an amber light displayed on the camera.Technical service walked the representative through ndi toolbox to check the status.The representative reported "scu" connection failure.Then they checked the self test and the psu and scu was red and not connected.They then removed the covers and checked the ethernet connections on both ends.After reseating both the ends, they checked the self test status again, error messages were still red.The representative tried another ethernet cable and checked the self test, error messages went away.The representative noticed the ethernet cable being kinked.

• Brand Name: STEALTHSTATION S8 SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12336065
• Report Number: 1723170-2021-02102
• Device Sequence Number: 4542155
• Product Code: HAW
• UDI-Device Identifier: 00763000272760
• UDI-Public: 00763000272760
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• 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
• Report Date (Section B): 08/18/2021

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: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 93