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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 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. Testing revealed that during troubleshooting representative switched monitors and determined the surgeon monitor was the cause. Replacing the monitor resolved the issue. The system then passed the system checkout and was found to be fully functional. The monitor was returned to the manufacturer for analysis. Analysis found that when connected to a known good system the monitor displayed a good image at power up but shortly afterwards went blank. Hot plugging the monitor resolved it but after short time the issue repeated. Analysis found that the reported event was related to a electrical issue. 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.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that the surgeon¿s monitor went black after inactivity during a demo. Restarting the system resolved the issue until the system was inactive again. There was no patient present when this issue was identified.
 
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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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7642948
MDR Text Key112562576
Report Number1723170-2018-03016
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2016
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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