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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 09/07/2017
Event Type  malfunction  
Manufacturer Narrative
The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to site to test the equipment. Representative reported that a computer was replaced. A system checkout was performed after replacing the part and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect monitor has been received by manufacturer for evaluation. The received computer booted normally to application screen. Computer passed all testings. Near completion of simulated use of system video dropped out. System on reboot has video but performance was lagging. Hard disk drive (hdd) and ram displayed no errors but the video issue was intermittent.
 
Event Description
A medtronic representative reported that while outside of procedure, when the spine application was launched on navigation system, both monitors of the system displayed blank. During troubleshooting, representative launched cranial application after hard rebooting the system, the top half of both monitors displayed software but was flashing and flickering. When the system was hard reboot and the cranial application was relaunched again both monitors displayed black. Staff cart monitor displayed no signal when the staff cart monitor was unplugged from video splitter. Representative hard reboot the system again and launched the admin appliance and the monitors displayed the admin with no issue. Restarting the system and launching the frame work did not resolve the issue as both monitors were only displaying top half of software and were flashing and flickering. When the video splitter was bypassed and the staff monitor was connected directly to computer, the monitor did not display correctly. There was no patient present at the time of the issue.
 
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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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key6914611
MDR Text Key102903827
Report Number1723170-2017-04019
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 11/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2017
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 Manufacturer09/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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