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

Model Number 9735665

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that during a new install, while assigning the ip address, receiving a "no route to host" error message.During an attempt to reboot, the system would then not shut down and a "no signal" error message was given on the camera cart.Self-test displayed a red ups and no battery indicator.V2 on the ups had no light illuminated, the rest of the lights were green except for the battery light that was illuminated amber.After checking all of the connections and reseating all of the cables, no changes appeared in self- test.The network router had no lights and appeared to not be working.Technical services (ts) was able to replicate the issues in the lab after disconnecting the network router.They replaced the checkpoint router and some of the issues were fixed.In self test, all internal connections are green, with the exception of the checkpoint and wifi endpoint.The system would power down correct through the software.Reboots did not change this behavior.Tried to connect to the checkpoint ip through a firefox window, but it stated no connection.When trying to configure the network information, the error message stating no route to host was still there.Ts shipping replacement checkpoint and computer (+mini-dp to dp cable).The issue either replies in the router portion (wan and dmc ports) of the checkpoint, as it seems like the switch (lan ports) portion is working fine or the network card in the pc is not functioning.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that not able to create mac address.Cpu issue unresolved, hardware was replaced.The system then passed the system checkout and was found to be fully functional.Analysis found on surgeon cart- analysis determined the system was tested and found to act as described.Checkpoint seems to not configured.Production refresh thumb drives do not have mac address for checkpoint in its history indicating that it was not configured.Once checkpoint was configured system functioned as expected.Analysis found on net sec app-wired- analysis determined the checkpoint was tested and found to not have a production configuration.Was able to log in to 192.168.1.1 and the new config wizard would initiate.When attempting to configure using refresh memory stick, unit would would not finish configuring and the log indicated that it was "unable to retrieve information from user center (connection error)" when unit is installed into system, self-test indicates communication errors to the checkpoint and wifi endpoint, all other main cart ip components are green.Other relevant device(s) are: product id: 9735994, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant product: product id: 9735785, lot #: unknown, ubd: unknown, udi #: unknown product id: 9735764, lot #: 2126f00338, ubd: unknown, udi #: unknown product id: 9735994, lot #: nx2045o10440, ubd: unknown, udi #: unknown product id: 9736356, lot #: unknown, ubd: unknown, udi #: unknown product id: 9736355, software version #: 2.0.2 product id: 9735943, lot #: unknown, ubd: unknown, udi #: unknown h2, h3, h6: the returned cable was analyzed.No failures were found.Codes c19, and d14 are applicable, as is previously reported code b01.The returned computer was analyzed.No failures were found.Codes c19, and d14 are applicable, as is previously reported code b01.The returned system checkpoint was analyzed.No failures were found.Codes c19, and d14 are applicable, as is previously reported code b01.The returned ssd was analyzed.No failures were found.Codes c19, and d14 are applicable, as is previously reported code b01.Software analysis was performed.No failures were found.Codes c19, and d14 are applicable, as is previously reported code b01.The returned power pack was analyzed.No failures were found.Codes c19, and d14 are applicable, as is previously reported code b01.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13052904
• MDR Text Key: 289894839
• Report Number: 1723170-2021-02933
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000359881
• UDI-Public: 00763000359881
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 12/03/2021
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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
• Treatment: "SEE H10...."; SEE H10