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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 11/17/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative inspected the navigation system onsite and confirmed the issue. The representative attempted to perform a system checkout by uninstalling/reinstalling the software, however the computer was crashing. The system computer was replaced and the issue was resolved. A full navigation system check-out was completed following part replacement and all tests passed. Full system functionality was confirmed and the system was returned to service. No parts have returned to the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while outside of a procedure while pulling logs from cranial, the top 1/4 of the monitor on the navigation system would begin flickering between a block screen and the software. The remaining 3/4 remained completely black. The representative rebooted the system and entered cranial again and the system appeared to act normal until attempting to pull the logs again, the same issue occurred. To trouble shoot, the representative booted into spine and after approximately 3 minutes in spine, the monitor would display 'no input detected' and would not display an image at all with cord reseats. There was no patient present when this issue was observed. 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
stephanie riley
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7118582
MDR Text Key94973045
Report Number1723170-2017-05153
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,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2017
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? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2011
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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