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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 Imprecision (1307)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2016
Event Type  malfunction  
Manufacturer Narrative
Onsite investigation was preformed and the field systems engineer was unable to replicate the reported event.System functioned as designed and without issues.He noted that the inaccuracy was noticed more superficially and as they proceeded in the sinus the accuracy got better.The scan they were using was taken approximately 40 days prior to the procedure.A full system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.
 
Event Description
A site representative reported that, while in a functional endoscopic sinus surgery, the surgeon felt accurate on the nose, but then when using the navigated blade, felt inaccurate.The surgeon went back to the tracer probe and was inaccurate again.They re-registered, and this time some of the tracer points were collected superior to anatomy that was actually included in the scan; the scan was missing the forehead, and they were still inaccurate on the tip-of-the nose by about 2-3 cm.The case was continued with the use of navigation.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.
 
Manufacturer Narrative
A medtronic representative, following up with the site, reported that there have been no additional occurrences since this event.The software investigation was unable to determine the probable cause without further information.However it is suspect that the issue was compounded by possible poor tracer pattern and the use of an older scan.The instructions for use (ifu) that accompanies the device provides guidance for multiple registration methods.
 
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Brand Name
STEALTHSTATION S7 SYSTEM
Type of Device
NEUROLOGICAL 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
kristianna bilan
826 coal creek circle
louisville, CO 80027
7208902338
MDR Report Key6194237
MDR Text Key62968245
Report Number1723170-2016-05847
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
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 Health Professional
Type of Report Initial,Followup
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberS7
Device Catalogue Number9733856
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/28/2016
Initial Date FDA Received12/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age54 YR
Patient Weight71
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