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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735665
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2018
Event Type  malfunction  
Manufacturer Narrative
Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. Testing revealed that after an imaging spin trajectory 1 view was not available, re-pushing the last imaging spins images to navigation system and trajectory 1 images were visible and accurate. The system then passed the system checkout and was found to be fully functional.
 
Event Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure. The issue occurred intraoperatively during the navigate task and delayed the surgery by less than one hour. It was reported that during an imaging device case, after an imaging spine completion the trajectory 1 view was showing a blank screen. The trajectory 2 view would show the anatomy and instrument model. After re-pushing the last imaging spin to navigation system , images for trajectory 1 were visible and accurate. The surgery was completed with navigation and there was no known impact on patient outcome.
 
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.
 
Manufacturer Narrative
Correction: report source: foreign.
 
Manufacturer Narrative
Additional information: device manufacture date provided. Correction: sequence number mdrs 2 and 3 inadvertently filed. Should have been filed under mdr 1723170-2017-03450 not mdr 1723170-2018-03450.
 
Manufacturer Narrative
Software investigation was initiated to determine probable cause. Per engineering review, logs and case details were reviewed but provided no additional insight into the cause. The software investigation was unable to determine probable cause of the issue without further information. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction: information submitted on manufacturer report # 1723170-2018-03450 follow-up numbers 1 and 2 do not pertain to this event. They pertain to the event detailed in manufacturer report # 1723170-2017-03450. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION S8 PREMIUM 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 Key7546007
MDR Text Key114046050
Report Number1723170-2018-03450
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2018
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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