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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC S8 EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735736
Device Problem Computer Software Problem (1112)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from a manufacturer representative (rep) regarding a navigation system being used for a procedure. The rep reported that during the registration task when they tried to place the patient reference frame on the side of the patient model it was consistently floating above the registration model instead of sitting on the skin. The rep adjusted the 3d model to clean it up and it still occurred. The only place that the issue did not occur was high above the right eye and the rep noted that this issue had happened in every clinical case so far. There was a patient involved with the issue, but there was no impact or change to patient outcome. There were no further complication reported or anticipated.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through design analysis. Analysis found that the behavior described is the intended behavior of the software. Software is functioning as designed. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A medtronic representative went to the site to test the navigation system. The system was passed all test and was found to be fully functional. No parts required replacement. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Follow-up with manufacturer reps determined that the system would fail to boot up, but the two times it occurred they were able to type in lines with unburnt and replacement of the defective hard drive. The rep then indicated the site now traces without the reference frame and the floating was about 4 mm off the model. The surgical delay was reported as about 5 minutes.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received which indicated that the issue occurred during a fess procedure. The rep indicated that from the log files on the day of the case and the rep was able to see that on the demo model the patient tracker was hovering above the skin model on the registration page. However, the rep was able to successfully register the model with no issues. The rep did not know if there was any change in patient outcome or delay in surgery.
 
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Brand NameS8
Type of DeviceEAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8159496
MDR Text Key130266719
Report Number1723170-2018-06230
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735736
Device Catalogue Number9735736
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2019
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 Unkown

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