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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 EM ENT SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 EM ENT SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735669
Device Problems No Display/Image (1183); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 02/22/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. It was reported that the osd menu was unlocked on the navigation system and that the power button was enabled. Once pushed, the monitor functioned as designed. No additional information was provided.
 
Event Description
A medtronic representative reported that, while outside of a procedure, the monitor for the navigation system lost display functionality. When powered back on, the application software did not display the splash screen. There was no patient present when this issue was identified. No additional information was provided.
 
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Brand NameSTEALTHSTATION S8 EM ENT 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
MDR Report Key7351317
MDR Text Key102861090
Report Number1723170-2018-01176
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
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 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735669
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 Received02/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2016
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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