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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the issue could not be replicated. 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. It was reported that while navigating, the device became unresponsive. The mouse was not moving. After rebooting, the site was able to proceed with case. Surgery was delay for less than an hour and there was no known impact on patient outcome.
 
Manufacturer Narrative
The logs for the navigation system were reviewed by medtronic personnel. An instance of logging ceasing was noted after an instrument was instrument was introduced into the surgical field. However, the logs provided no additional insight into the probable cause of the anomaly.
 
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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
7208902515
MDR Report Key7659814
MDR Text Key113188527
Report Number1723170-2018-03120
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
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 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733927
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 Received08/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2010
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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