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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 No Display/Image (1183); Device Operates Differently Than Expected (2913)
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. A manufacturer representative went to the site to test the equipment. The computers were replaced. The navigation system then passed the system checkout and was found to be fully functional. The computer (lot # 1777076) was returned to the manufacturer for analysis. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The suspect computer (lot # 1766760) was returned to the manufacturer for evaluation. However, results are not available at this time.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that when booting the system, it took a while to select the application. System suddenly became unresponsive while site was selecting the patient. Site attempted reboot, but display was blank. Site noted that system's fans were running at this time. Twenty minutes passed and site attempted another reboot. Application took a long time to launch, but reboot was successful. There was no patient present when this issue was observed.
 
Manufacturer Narrative
A software analysis was initiated. However, the software evaluation found no software anomaly. Software functioned as designed.
 
Manufacturer Narrative
A second computer for the navigation system was returned to the manufacturer for analysis. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
Correction: medtronic representative reported that previously reported second computer (lot # 1766760) was returned unused.
 
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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
koko tyler
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208903200
MDR Report Key7604012
MDR Text Key111146304
Report Number1723170-2018-02663
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2009
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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