• 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. (LOUISVILLE) STEALTHSTATION S7 SYSTEM 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. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems Erratic or Intermittent Display (1182); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. The suspect computer was returned for evaluation, however results are not yet available.
 
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the system was intermittently unresponsive. The issue has been happening in multiple stages of the software. During the call, while in the planning screen and scrolling through slices, the system stopped responding to the user's input, and the keyboard did not respond to any user input including an attempt to soft reboot the system either. Additionally, the mouse was also no longer responsive to the user's input. During troubleshooting, they restarted the system and after restarting, the system stopped responding once again and once it stopped responding, the display began to show artifacts on the screen. After restarting the system one more time, the system started responding. There was no clinical impact or patients present.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the "system freezes up" and the computer required replacement. The computer was replaced and the imaging system then passed the system checkout and was found to be fully functional. The computer was returned to the manufacturer for analysis. Analysis found that the initial boot and navigation of applications, memtest86, and phd all passed testing. Seatools long test failed. The short and long test passed after the repair of bad sectors via seatools disc. Analysis found that the reported event was related to a hard drive malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
erika mitchellette
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7609433
MDR Text Key111323033
Report Number1723170-2018-02814
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 company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 07/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733927
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-