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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733560XOM
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The system passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess). It was reported that the surgeon felt inaccurate by approximately 10 mm. The site reported that the top of the patient's head was missing and there wasn't sufficient real estate to trace effectively. The surgeon did not perform point merge. There was no known impact on patient outcome. There was a reported delay to the procedure of less than 1 hour due to this issue.
 
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Brand NameFUSION¿ ENT NAVIGATION 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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8723661
MDR Text Key148826588
Report Number1723170-2019-03738
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733560XOM
Device Catalogue Number9733560XOM
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 Received03/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/21/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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