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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 Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue.
 
Event Description
A site representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system was intermittently tracking instruments. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact on patient outcome. No additional information was provided.
 
Manufacturer Narrative
A manufacturing representative completed a work order on the device. The system passed all work order requirements. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7375339
MDR Text Key103660565
Report Number1723170-2018-01333
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2013
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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