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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) STEALTHNAVIGATOR ENAV SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LITTLETON) STEALTHNAVIGATOR ENAV SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ENAV
Device Problems Imprecision (1307); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative reported that the system was functioning as designed. The tracer pattern used on the navigation system was to specifications, however fiducialas were not used in the procedure. The representative recommended to the surgeon that the fiducials be used in future procedures.
 
Event Description
A medtronic representative reported that, while in a cranial resection, the surgeon felt inaccurate during the procedure at times. The representative reported that the surgeon continued to use the navigation system while also having an ultrasound present for additional use. No additional information was provided. There was no reported delay to the procedure due to this issue. There was no impact on patient outcome.
 
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Brand NameSTEALTHNAVIGATOR ENAV SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LITTLETON)
300 foster street
littleton MA 01460
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LITTLETON)
300 foster street
littleton MA 01460
Manufacturer Contact
peter verhey
826 coal creek circle
louisville, CO 80027
MDR Report Key6210205
MDR Text Key63413519
Report Number1723170-2016-05877
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberENAV
Device Catalogue Number9733658
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2007
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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