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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); Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that all systems were found to function as expected. The system then passed the system checkout and was found to be fully functional.
 
Event Description
Medtronic received information regarding a navigation device being used for a cranial resection procedure. It was reported that the orthogonal views were found to be black. The site was navigating on a 3d model and the issue was observed awhile into the navigation. It was confirmed that the exam was selected and one computed tomography (ct) was being used. The frame and instrument were viewed as green and in the lower right. The site rebooted the system and cycled views, however the issue did not resolve. Surgical time was delayed by 45 minutes and completed without the use of navigation, and no reported impact on patient outcome.
 
Manufacturer Narrative
A software investigation analysis was initiated to determine the probable cause of the issue through analysis found that the analysis was inconclusive and probable cause was unable to be determined. Logs were reviewed but provided no additional insights regarding the reported complaint. If information is provided in the future, a supplemental report will be issued.
 
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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
erika mitchellette
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7811529
MDR Text Key118095084
Report Number1723170-2018-04199
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
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
Report Date 02/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2018
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2013
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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