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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.It was reported that the computer of the navigation system was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The computer for the navigation system was returned to the manufacturer for evaluation.Testing found that the computer would display a sr manager failure as reported and that the computer would restart without prompt from the user after a few minutes.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.
 
Event Description
A medtronic representative reported that, while outside of a procedure, the navigation system displayed a sr manager failure message while in digital intercommunication of medicine (dicom) query retrieve (q/r).It was reported that the navigation system could enter application software as designed.There was no patient present when this issue was identified.No additional information was provided.
 
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Brand Name
FUSION NAVIGATION SYSTEM
Type of Device
NEUROLOGICAL 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
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7338796
MDR Text Key102400603
Report Number1723170-2018-01126
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994380005
UDI-Public00613994380005
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberFUSION
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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