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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 Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 03/05/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. No parts have been received by the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that, while outside of a procedure, the emitter would intermittently experience difficulties tracking instruments when there was no metal interference. There was no patient present when this issue was identified. No additional information was provided.
 
Manufacturer Narrative
The field generator was returned to the manufacturer for analysis. The field generator was connected to a known good axiem test system for a twenty four hour burn-in test. The system remained in green status throughout all testing. The reported problem could not be duplicated.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that a field generator was replaced to resolve the issue. The system then passed the system checkout and was found to be fully functional.
 
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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 Key7370570
MDR Text Key103462474
Report Number1723170-2018-01313
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
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 Received07/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2012
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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