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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 Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2017
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
 
Manufacturer Narrative
Additional information: patient weight provided.
 
Manufacturer Narrative
Patient weight not available from the site. The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
 
Event Description
A medtronic representative reported that, while in the procedure in mdr 1723170-2017-04314, an imprecision was observed when utilizing the straight suction. The surgeon opted to complete the procedure without the use of the navigation system. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no impact on patient outcome. No additional information was provided.
 
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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 Key7102208
MDR Text Key104086299
Report Number1723170-2017-05039
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,Followup,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
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 Received09/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2010
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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