• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEALTHSTATION® S7¿
Type of DeviceNEUROLOGICAL 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 Key13006055
MDR Text Key286443957
Report Number1723170-2021-02888
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
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 Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-