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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 Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
No parts have been received by the manufacturer for evaluation. No components received.
 
Event Description
Medtronic received information that during a procedure while navigating the emitter went red and all instruments and trackers stopped tracking. They rebooted the system with no solution. They checked the eminterface, one fault was shown and the axiem box was showing green status while the emitter was showing red while plugged and then again when replugged in. The surgeon chose to discontinue use of this navigation system and used another navigation system that was on-site. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact to the outcome of the patient.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that a field generator was replaced. The system then passed the system checkout and was found to be fully functional. No further issue have been reported with the system. The field generator has been received by the manufacturer for evaluation. The field generator was returned to the manufacturer for analysis. Analysis found that the emitter and all instruments displayed a red status. The eminterface shows a fault on coil 2. The axiem box displayed a green status briefly when first plugged in but remained in a red status through testing. Analysis found that the reported event was related to a electrical issue. 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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7488967
MDR Text Key107454726
Report Number1723170-2018-01906
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
Report Date 05/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
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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