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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number I7
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 08/27/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Unique device identifier (udi) is unavailable. A medtronic representative went to the site to test the equipment. Testing revealed an issue with the transceiver. It was found that upon accessing plan/navigation in the application, the surgical monitor was found to blink, and displayed message ¿searching for signal¿. No parts have been returned to the manufacturer for analysis. Manufacture date is unavailable.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the mounted screen lost its image after extended usage throughout the day. There was no patient present when this issue was observed.
 
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Brand NameSTEALTHSTATION I7 INTEGRATED NAVIGATION 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 Key7881547
MDR Text Key120433618
Report Number1723170-2018-04698
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994667458
UDI-Public00613994667458
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberI7
Device Catalogue Number9734061
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2010
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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