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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 Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. A medtronic representative went to the site to test the equipment. Testing revealed that system functioned normally. The system then passed the system checkout and was found to be fully functional. Device manufacturing date is unavailable.
 
Event Description
Medtronic received information regarding a navigation device being used for a catheter-based procedure. It was reported that, intraoperatively during the navigation task, there was an axiem tracking failure. The surgeon registered correctly and navigation was accurate; registration was taken over the whole head as is recommended. The surgeon marked the site for incision and burr hole. After scrubbing, the surgeon used the stylet to navigate; when the surgeon moved the stylet to the entry point at the back of the head, the image went blank. Navigation was accurate at the front of the head and accuracy maintained throughout. Both the tracker and probe remained green and visible. The surgeon stopped and unstopped navigation using the foot pedal and flicked through screens to try different things. Eventually it worked but the surgeon was unsure how. There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.
 
Manufacturer Narrative
Additional information: device manufacture date provided. Correction: product, unique device identification (udi), and related fields updated to proper value.
 
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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
7208903200
MDR Report Key7615877
MDR Text Key111560940
Report Number1723170-2018-02858
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2009
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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