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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 Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Patient Involvement (2645)
Event Date 03/15/2018
Event Type  malfunction  
Manufacturer Narrative
A manufacturer representative went to the site to test the equipment. Testing revealed that the computer of the navigation system was replaced to restore functionality. The system then passed the system checkout and was found to be fully functional. The computer of the navigation system was returned to the manufacturer for analysis. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Event Description
A manufacturer representative reported that, while setting up for a procedure, the navigation system became unresponsive when verifying instruments. There was no patient present when this issue was identified. No additional information was provided.
 
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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
MDR Report Key7403141
MDR Text Key104734922
Report Number1723170-2018-01485
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 04/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2013
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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