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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 Erratic or Intermittent Display (1182)
Patient Problem No Patient Involvement (2645)
Event Date 08/02/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Onsite functional and visual examination was performed by a manufacturer representative. The surgeon monitor and surgeon monitor cable were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. The cable was returned to the manufacturer. Functional testing found that the component had no issues and performed within specifications. The monitor was returned to the manufacturer. Functional testing found that the component was defective and was not displaying an image consistently.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that the surgeon monitor was turning black. They reseated the cable and it turned on for about 30 seconds, but then turned black again. There was no patient present.
 
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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
parker desautel
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7819610
MDR Text Key118394151
Report Number1723170-2018-04250
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 Biomedical Engineer
Type of Report Initial
Report Date 08/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2018
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 Manufacturer08/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2016
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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