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.

• 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
• 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

• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

0 Patients were 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

• 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