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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 Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue. It was reported that the touch screen of the monitor was inaccurate and that the monitor could not be recalibrated. It was noted that the plug at the back of the monitor was hot. The monitor was then replaced by the medtronic representative. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The monitor was returned to the manufacturer for evaluation. Testing found that the display of the monitor was pushed in on the upper right corner, away from the bezel. However, the monitor passed functional testing.
 
Event Description
A medtronic representative reported that, while in a procedure, that the navigation system was intermittently losing functionality. The reported issue was described as a "flickering" sensation. It was reported that the issue would occur when an instrument was introduced into the surgical field. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no known impact on patient outcome. No additional information was provided.
 
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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
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7102792
MDR Text Key94407707
Report Number1723170-2017-05058
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2017
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 Manufacturer11/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
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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