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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 Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
Correction: correct manufacture date received.
 
Manufacturer Narrative
The manufacturer conducted a hardware review and was unable to confirm the reported issue. No further action required.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The archive used in the procedure was sent to medtronic for evaluation. When loaded on a known operational navigation system, it was noted that the exams were not compatible. The navigation system displayed that the exams were not to protocol, as the slicing and thickness were higher than recommended values. Also, 6 of 8 datasets lacked a proper amount of slices.
 
Event Description
A medtronic representative reported that, while in an orbital decompression, an imprecision was observed once the site went sterile for the procedure. It was reported that registration and verification was successful when non-sterile. Once draped, the imprecision was observed. The imprecision as noted to be between 4-5 millimeters, it was noted that the malleable suction was accurate medially when entering the sinus cavity through the eye. The surgeon opted to complete the procedure without the use of the navigation system. The surgeon opted to complete the procedure without the use of the imaging system. There was a reported delay to the procedure of less than 1 hour due to this issue. 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
stephanie riley
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7118243
MDR Text Key103035944
Report Number1723170-2017-05079
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,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 07/30/2018
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 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 Received07/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2017
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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