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

Model Number 9735665

Device Problems Communication or Transmission Problem (2896); Device Sensing Problem (2917)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding an navigation system being used during an unknown procedure.It was reported that during surgery, the reference frame was intermittently being tracked by the camera.The site performed a system reboot and added/removed the reference frames from the procedure.The site did change the reference frames from the original navigation system to a different navigation system, as well as the spheres.Different angles were also attempted with the navigation system's arm.The 'bair hugger' and suction were turned off in the room.It was noted that the reference frame was going out every 11 seconds consistently.Once the navigation system was rebooted, the cranial frame was removed and a different navigation system frame was added.Initially, the navigation system reported it was not communicating with the imaging system although it was connected.After changing a plug in the back, the site was able to obtain images.This issue occurred intraoperatively and caused a surgical delay of less than one hour.There was no impact on patient outcome.Additional information was received.The issue was only occurring when connected to the imaging sys tem.The manufacturer representative checked the nditoolbox, and it showed all normal statuses for the system control unit (scu.) the event logs were empty.The scu did have a status message stating "invalid command." additional information received.It was reported this occurred during a cervical spine procedure.Additional information received.It was concluded that the frames was not the issue and the issue was a cord that fed into the camera.That was replaced and so far no more issues have occurred.

Manufacturer Narrative

Device evaluated by mfr: wo00872770- a medtronic representative went to the site to test the equipment.Testing revealed that no failure found.The system then passed the system checkout and was found to be fully functional.(b)(4).Device evaluated by mfr: wo00873944- a medtronic representative went to the site to test the equipment.Testing revealed that the bulkhead/cable was replaced.The system then passed the system checkout and was found to be fully functional.(b)(4).Analysis found on cable/bulkhead- analysis determined there was no failure found.(b)(4).Continuation of concomitant medical products: other relevant device(s) are: product id: 9735843, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 9735859, sn/lot # unknown additional information was received.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: 13011500
• MDR Text Key: 289900916
• Report Number: 1723170-2021-02893
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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?: No
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 106 KG