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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION
Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2018
Event Type  malfunction  
Manufacturer Narrative
Udi not available for this system at time of filing. Device manufacturing date is not available for this system at time of filing. No parts have been received by the manufacturer for evaluation. No parts returned for analysis.
 
Event Description
Information was received from a health care professional via manufacturer representative regarding a navigation device being used for a functional endoscopic sinus surgery (fess). It was reported that after registration, the system became unresponsive and it was not possible to get the system to function. The mouse was frozen, everything was unresponsive, and the crosshairs were red. There was a reported delay to the procedure of 15 minutes as a result of this issue and no impact on the patient outcome.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided. Correction: product and associated fields updated to proper value. The computer for the navigation system was returned to the manufacturer for analysis. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
Correction: a medtronic representative went to the site to test the equipment. Testing revealed that the computer of the navigation system was replaced to restore functionality. The system then passed the system checkout and was found to be fully functional. The analysis of the computer of the navigation system was completed by medtronic personnel. Testing found that the cpu or mb of the computer had a failure. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
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Brand NameFUSION NAVIGATION SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7404957
MDR Text Key104808789
Report Number1723170-2018-01511
Device Sequence Number1
Product Code HAW
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 06/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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