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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 Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Patient Involvement (2645)
Event Date 04/16/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device udi not provided. Device manufacturing date is unavailable. No parts have been received by the manufacturer for evaluation. Part not returned for evaluation.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the site was loading a patient exam and the system jumped back to the logo screen. The site rebooted the system and the issue was resolved. There was no patient present when this issue was identified.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through known anomaly determination. Analysis found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software 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
MDR Report Key7502850
MDR Text Key107965085
Report Number1723170-2018-01962
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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