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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 Problems Imprecision (1307); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2018
Event Type  malfunction  
Manufacturer Narrative
Patient race and ethnicity was unavailable from the site. A medtronic representative went to the site to test the equipment. The navigation system then passed the system checkout and was found to be fully functional. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation system during a cranial tumor resection. It was reported that the site was having trouble registering a patient. The surgeon was performing an optical registration on a prone patient. They attempted various times and had a couple of registrations that passed but the surgeon felt were inaccurate. The surgeon tried a tracer pattern followed by adding touch points. During one registration attempt, the registration flipped posterior to anterior after the surgeon added to the tracer pattern. The pattern was not un-done and at this point the surgeon decided to proceed without the use of navigation or imaging. The surgery was completed successfully with a 45 minute delay.
 
Manufacturer Narrative
Device manufacture date provided. Unique device identification (udi) updated to proper value.
 
Manufacturer Narrative
The logs for the navigation system were reviewed by medtronic personnel. However, the logs provided no additional insight into the probable cause of the anomaly. The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
 
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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
MDR Report Key7623977
MDR Text Key111942764
Report Number1723170-2018-02902
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
Type of Report Initial,Followup,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
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 Received08/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2018
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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