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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 Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/11/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. No parts have been received back to the manufacturer. A replacement imaging system power supply was provided, but the customer has declined to return the potentially malfunctioning part to the manufacturer. No parts were received by the manufacturer.
 
Event Description
A site representative reported that the navigation system unexpectedly powered off. There was no patient present when this issue was identified. No additional details were provided.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
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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
826 coal creek circle
louisville, CO 80027
7208902439
MDR Report Key6155756
MDR Text Key61875814
Report Number1723170-2016-05710
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeES
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
Report Date 03/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2016
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2014
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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