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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 Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2018
Event Type  malfunction  
Manufacturer Narrative
Device lot number, or serial number, unavailable. Manufacturing date was unavailable at the time of filing. No parts have been 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 for a functional endoscopic sinus surgery (fess). It was reported that the magnetic field stopped responding in the middle of using the reported product. When checking the setting screen, it was found that the line of the emitter became orange and the magnetic field failed to respond. No improvement was observed despite taking actions such as disconnecting and reconnecting the cord. The system was rebooted and the issue was resolved. There was a reported delay of 5 minutes and no reported impact to patient outcome.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. It was reported that the issue could not be confirmed or replicated, no components were replaced. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the system serial number was received and added. 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 Key8193334
MDR Text Key131298950
Report Number1723170-2018-06427
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153247
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 04/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2018
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
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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