• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC FUSION ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733560XOM
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9731203, serial/lot : unknown. A medtronic representative went to the site to test the equipment. It was reported that the issue could not be confirmed or replicated, no components were replaced. The manufacturer representative was able to track through the full volume of the emitter without issue. Complete system checkout was pending. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system that was used during a functional endoscopic sinus surgery (fess) procedure. It was reported that the surgeon was having issues tracking the instruments. Navigation was aborted. The issue resulted in less than one hour procedure delay. There was no known impact on patient outcome. On 2019-dec-17 additional information received stating the manufacturer representative could not replicate the issues while he was on site. The manufacturer representative was able to track through the full volume of the emitter with no issues.
 
Manufacturer Narrative
Additional information was received stating the system was functioning as intended. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFUSION ENT NAVIGATION SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9565295
MDR Text Key184460120
Report Number1723170-2020-00093
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733560XOM
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-