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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INSTR TRACKER EM ENT INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC INSTR TRACKER EM ENT INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733533
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
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 when trying to navigate on the screen, they had a low performance error. The exams only had 283 sliced and the spacing was not optimal but was 1x7. They had one patient tracker plugged in and three instrument trackers plugged in. One of the instrument trackers was non-sterile used to verify the instruments. The medtronic representative (rep) unplugged that tracker and the error went away. The rep unplugged different instrument trackers to make sure it was just the one. There was a delay of less than one hour and no impact to the patient. This was noted to be an out of box failure for the tracker.
 
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Brand NameINSTR TRACKER EM ENT
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 Key10670687
MDR Text Key211284407
Report Number1723170-2020-02690
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733533
Device Catalogue Number9733533
Device Lot Number200214C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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