• 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 COMPACT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

  • 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 COMPACT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735602
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that while attempting to load an exam disc, an "unable to interpret header data" message appeared on the screen. The exam was re-burned at the same issue occurred with unstructured alternate module and standard. The likely cause of the issue is compression. There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFUSION COMPACT
Type of DeviceEAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11448931
MDR Text Key238931321
Report Number1723170-2021-00631
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735602
Device Catalogue Number9735602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-