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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 Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/17/2017
Event Type  malfunction  
Manufacturer Narrative
The medtronic representative was already onsite and troubleshooting. Upon follow-up, the medtronic representative reported that the navigation system seems to be working properly after unplugging and plugging all the cords back in making sure they were all properly seated. They had a case after the medtronic representative did this and it worked perfectly fine with the surgeons monitor staying on throughout the entire case. This site has done cranial and shunt cases without us there and have not complained about the screen doing what it used to do. Issue resolved with reseating the cables. No parts were replaced. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A medtronic representative reported that the navigation system's surgeon monitor intermittently turns black. Unseating/reseating the external surgeon monitor cable tends to resolve the issue. 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
oksana ditolla
826 coal creek circle
louisville, CO 80027
MDR Report Key6408524
MDR Text Key70066046
Report Number1723170-2017-01201
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2017
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? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2013
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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