MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733856

Device Problems Computer Software Problem (1112); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: s7 argus os, version: 1. 2. A medtronic representative went to the site to test the equipment. Testing revealed that there was computer boot up failure. The computer was replaced and the new computer had no video output. The old computer got video. The computer was replaced again. It was found that the fan wire was going from computer to multi out. The system was rewired and the issue was resolved. The software investigation found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that upon boot up they got an unrecoverable error stating sr manager failure. Technical services had them remove the cd from the disc drive and reboot the system. They were able to launch the application but the cd would not load it's contents. Technical services had them access the file system to find the cd and it was still not loading the dicom. There was no patient present. Additional information was received from the field and it was noted that after replacing the computer on the system, the monitors displayed a "no signal" message. They reseated all of the connections and walked over the connections with the technical services. They checked the video splitter as well as by passed it. They still received a "no signal" message. Then bypassed the new computer to the old computer and both monitors worked as intended indicating a fault in the new computer. It was further reported that after they put the 2nd computer replacement in the system and continued to get an immediate no signal upon boot up. It was confirmed that the video cable was in the correct port on the computer. Technical services had her bypass the video splitter with no change. The video splitter did not have the active light on when the cables were plugged in. They remove all peripheral connections (except the video, power and cd) and there was no change. The rep pressed the cmos reset with no change. The computer fan was running and there were no visible damaged/loose cables. Through troubleshooting, it was discovered that the fan power output cable was seated in the multiout instead of in the three prong cable form the cd drive. Both fans were now fully functional.

• Brand Name: STEALTHSTATION® S7¿
• 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: 13006055
• MDR Text Key: 286443957
• Report Number: 1723170-2021-02888
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse