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

Model Number 9735665

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The system was serviced in the field and there was no connection to the ups or the networks.The router and wifi end point were replaced and the failure was resolved.Internal analysis was done at the site.It was reported that router was faulty.Both parts were replaced and the issue resolved.The site it was given new wireless mac address from endpoint.Endpoint was connected to the dmz port in router.The manufacturer representative confirmed all the navigation systems at the site were set up for statically wired connections (spine/o-arm) and wirelessly for cranial procedures.The static-wired configuration was set up.After configuration, no wireless ip address information was saved.Upon boot up in cranial dicom, lists wireless ip as not available.In self-test tool it lists wireless ip as not connected.On internal network status, everything is green, connected.Technical services recommending systematic approach to troubleshooting and highly advised remote support.It was later reported that the system was working as intended.The system successfully joined the hospital's wifi network, then was set up as static for the wired configuration and both generated and saved the ip addresses.It was likely a hospital networking issue that resolved overnight, as site it just enabled the system's new endpoint to access wifi the previous day.The wifi end point was returned and analyzed.Initially it would not connect to the test network.Once the endpoint was factory reset and reconfigured, communication was reestablished on both 2.4 and 5 ghz test networks.The router was returned and analyzed.The checkpoint was tested and found to connect to a wifi network as expected using a known good endpoint and 2.4 and 5ghz test networks.Concomitant medical products: product id: 9735797, serial/lot #: (b)(4).Product id: 9735799, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that while setting up for a case, there were issues with this system connecting to wifi.After rebooting, dicom transfer page listed the not available for wireless.The site switched to another system.This was reported outside of a procedure.There was no patient involved.It was later reported that the local representative (cs) was on site to replace the endpoint when in the self-test, he noticed that the uninterrupted power supply (ups) of both carts were disconnected.He then went into the internal network connections tab and saw that all the connections were unavailable/red besides the surgeon computer.

• Brand Name: STEALTHSTATION S8 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11030714
• MDR Text Key: 222724264
• Report Number: 1723170-2020-03317
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1