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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735669
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
Information was provided regarding internal analysis. It was stated that inspection was done by the service and repair team which revealed no abnormalities. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess). It was reported that, at the time of registration, the accuracy did not increase from 2. 7mm with the instrument. The gap in accuracy could be confirmed. It was clarified that the time, a 3-point registration was performed but the first point came out on the chin and was moved to the tip of the noise. The second point could not be achieved no matter how many times it was performed. It was noted there was no problem with the interface value. They switched to a normal tracer, added touched and registration was repeated several times with a maximum accuracy of 2. 7mm. Registration was repeated several times which took a long time. The health care professional was unhappy with how long it was taking for the registration to be completed so a different navigation system was brought in and registration was completed successfully. It was reported that the anesthesia time became longer. Further information regarding a potential cause of the event was received. It was noted that the chin seemed to be raised at the time of imaging, and registration could not be performed with that posture. Regarding the building method of the registration model, the navigation systems had a "stealth-only" format but the "ss" was built from digital imaging and communications in medicine (dicom) data to ensure accuracy, and recognition became more severe. It was noted that there was no delay and no impact to the patient.
 
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Brand NameSTEALTHSTATION S8 SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10750091
MDR Text Key214405021
Report Number1723170-2020-02825
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735669
Device Catalogue Number9735669
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Yes
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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