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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 Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
The analysis on the computer of the navigation system was completed by medtronic personnel. Testing found that the hard drive had 4095 reallocated sectors. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database. 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.
 
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative inspected the navigation system onsite and after attempting to log in to the cranial application the system locked up on a black "loading. Please wait" screen. The system required a hard reset. On the second attempt it took 20 minutes to log in to the cranial software and the system locked up on the registration screen. The representative uninstalled and reinstalled the cranial software. The system loading issue persisted after the uninstall, reinstall. The computer was replaced and the issue resolved. A full navigation system check-out was completed following part replacement and all tests passed. Full system functionality was confirmed and the system was returned to service. The suspect computer has been returned to the manufacturer for evaluation, however results are not available at this time.
 
Event Description
A medtronic representative reported that while outside of a procedure, the navigation system unexpectedly shut down. While setting up for a case, the navigation system would repeatedly shut down unexpectedly when attempting to set up the points for a point merge registration. It was reported that the site could enter the cranial software, but upon adding points, the monitor would go black and the system would shutdown. There was no patient present when this issue was observed and the site used a second navigation system to complete cases.
 
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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
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7152373
MDR Text Key103052269
Report Number1723170-2017-05320
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2013
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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