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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735602
Device Problem Mechanical Problem (1384)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A medtronic representative went to the site to test the equipment. Testing revealed that the system becomes unresponsive. The re presentative replaced the axiem box and the external cable. The system then passed the system checkout and was found to be fully functional. No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used during a procedure. It was reported that the system operated without problems until the site came to the registration and the instrument could not be used. The system froze after a certain period of time after. The site was able to proceed with the case by restarting the navigation system. It is if there was any delay to the procedure and patient outcome is unknown.
 
Manufacturer Narrative
Additional information: no patient involvement. Analysis on the returned axiem box resulted in no failure being found through functional testing and visual/physical examination. Analysis states that upon initial connection, all eight ports were tracking. The device remained fully functional throughout the entire duration of testing. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was confirmed that this issue occurred outside of procedure and no patients were involved.
 
Manufacturer Narrative
Correction: the date received by manufacturer was 02/04/2019 on the followup1 (1723170-2018-06169) mdr submission. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis on the returned axiem communication cable resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the cable was found to be in good condition and was fully functional when connected to a known good system. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameFUSION COMPACT
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 Key8147779
MDR Text Key129913418
Report Number1723170-2018-06169
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
PMA/PMN Number
K153247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735602
Device Catalogue Number9735602
Device Lot Number2062136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2018
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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