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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 Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Patient Involvement (2645)
Event Date 04/12/2018
Event Type  malfunction  
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 the screen reads no signal and rebooting multiple times did not resolve the issue. It was reported that a central processing unit (cpu) was replaced to resolve the issue. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect part has not been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information that, while outside of procedure, when exiting the cranial application, the system would go into "no sync" for 5-10 minutes before loading the application launcher. There was no patient preset at the time of the issue.
 
Manufacturer Narrative
The computer was returned to the manufacturer for analysis. Analysis found that computer was able to boot the application. The computer also passed memory and hard drive tests. No fault has been found.
 
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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
7208902515
MDR Report Key7488813
MDR Text Key107458357
Report Number1723170-2018-01905
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 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2018
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 Manufacturer05/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2012
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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