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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 No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 01/26/2018
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 both the replacement laser handle and a know working handle did not resolve the reported issue. It was determined that the power supply unit (psu) required replacement. The system then passed the system checkout and was found to be fully functional.
 
Event Description
Medtronic received information regarding a navigation device. It was reported that while performing a planned maintenance (pm) on the system, it was found that the laser handle did not display the laser. This issue was noted outside of a procedure and no patient was present when this issue was observed.
 
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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
erika mitchellette
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7899064
MDR Text Key121450231
Report Number1723170-2018-04892
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994603678
UDI-Public00613994603678
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2013
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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