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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 No Display/Image (1183); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Unique device identifier (udi) is unavailable. Device manufacture date is unavailable. A medtronic representative went to the site to test the equipment. It was reported that the monitor of the navigation system was replaced. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The monitor has not been received by the manufacturer for evaluation.
 
Event Description
A site representative reported that, while outside of a procedure, the monitor of the navigation system lost display functionality without prompt from the user. It was noted that functionality was restored without prompt from the user. There was no patient present when this issue was identified. No additional information was provided.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date updated to proper value.
 
Manufacturer Narrative
The monitor for the navigation system was returned to the manufacturer for analysis. The monitor was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
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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 Key7396058
MDR Text Key104360560
Report Number1723170-2018-01434
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/14/2011
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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