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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 Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 03/16/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. The computer and uninterruptible power supply (ups) were returned to the manufacturer for evaluation. After functional testing, visual/physical examination, and proceduralized testing, no fault was found with the returned computer. The part passed all tests. After functional testing, visual/physical examination, no fault was found with the returned ups. All ac outputs were found to be functional. No problem was found.
 
Event Description
Information was received from a manufacturer representative regarding a navigation system outside of a procedure. It was reported that there was no signal on the staff and surgeon monitors. The representative confirmed that when the system was powered on and off, the camera beeps and has lights, but there was no power to the dis drive or mouse. The panels were removed to confirm the power cable to the computer was properly seated as well as to the uninterruptible power supply (ups). The ports of power were changed on the ups without resolution. There was no patient present when this issue was identified and occurred when replacing the computer.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative reported that the computer was replaced. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
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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
heather davis
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7405133
MDR Text Key104810963
Report Number1723170-2018-01514
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2013
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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