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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 Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
Following the initial troubleshooting determining that the scu for the navigation system. A replacement scu was shipped to the site. A medtronic representative went to the site to test the equipment. The representative reported that the replacement was performed on (b)(6) 2016. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The scu was then returned to the manufacturer for analysis. Testing found that the camera reported multiple intermittent internal strobe errors on the camera. This indicated an electrical failure due to the internal strobe errors.
 
Event Description
A medtronic representative reported that, while outside of a procedure, when demonstrating the cranial software for the navigation system that the camera displayed a red status and the screen showed "localizer not connected. " the representative restarted the system and that resolved the issue. The representative then left the computer on after the demonstration and the issue repeated. Initial troubleshooting determined that the scu for the navigation system required replacement. No additional information was provided. There was no patient present when this issue was identified.
 
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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
826 coal creek circle
louisville, CO 80027
MDR Report Key6209293
MDR Text Key63420464
Report Number1723170-2016-05948
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
Report Date 12/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2016
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 Manufacturer12/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2012
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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