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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 Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2016
Event Type  malfunction  
Manufacturer Narrative
On 11/14/2016 a medtronic representative, following-up at the site, reported the surgeon operated on the patient, with the exception of not completing the frontal sinuses.Pre-op, the surgeon stated not being confident performing the frontal procedure without navigation.- no parts have been received by manufacturer for analysis.- no further issues have been reported.Part not received by manufacturer.
 
Event Description
A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the site failed tracer registration 7-8 times.They also attempted pointmerge registration and were unsuccessful.The surgeon was using a stingray tracker.The medtronic representative recommended using a 3 point tracer.The surgeon opted to discontinue the use of the navigation system to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment and replaced the system monitor for an unrelated issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
 
Manufacturer Narrative
Device manufacture date 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
amos jarrette
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key6133936
MDR Text Key61096233
Report Number1723170-2016-05476
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberFUSION
Device Catalogue Number9733560XOM
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/01/2016
Initial Date FDA Received11/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received12/29/2016
02/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/30/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age43 YR
Patient Weight113
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