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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 Patient Involvement (2645)
Event Date 11/30/2017
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative inspected the navigation system onsite and confirmed the reported issue. The polaris spectra system control unit (scu) was replaced and the issue resolved. A full 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 manufacture for evaluation.
 
Manufacturer Narrative
Correction: the positioning sensor unit (psu) of the navigation system was replaced. The positioning sensor unit (psu) was returned to the manufacturer for analysis. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
The polaris spectra system control unit (scu) and scu to positioning sensor unit (psu) communication cable was returned to the manufacturer for analysis. The devices was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. No parts have been received by the manufacturer for evaluation.
 
Event Description
A site representative reported that while outside of procedure, the camera of the navigation system intermittently would not power on and would unexpectedly stop. It was reported that the camera would cycle during a case. There was no patient present at the time of the issue.
 
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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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7145396
MDR Text Key103047747
Report Number1723170-2017-05285
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2013
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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