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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 Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. Udi not available for this system at time of filing. System not evaluated as issue was resolved by reseating and cleaning cable. Device manufacturing date not available at time of filing. 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 a message appeared that there was no magnetic field emitted. The cable between the axiem controller box and the monitor was not connected. After the cable was connected and the system was restarted, the orange line did not change to green in the setup equipment screen, and it was noted the number on the back of the axiem controller box was ¿1¿. The usb and the port were wiped with an alcohol swap and the system was rebooted with resolve. There was no further issue. This use occurred preoperatively and did not cause any surgical delay. There was no reported impact on patient outcome.
 
Manufacturer Narrative
The cable was returned to the manufacturer for analysis. Analysis found that there were no issues with the returned cable. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The computer of the navigation system was returned without any accessories and was found to power up and connected with a known good axiem without issue. No issues were found. 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 Key8147557
MDR Text Key129930958
Report Number1723170-2018-06163
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/21/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
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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