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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC FUSION ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733560XOM
Device Problem Communication or Transmission Problem (2896)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 10/15/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 960-152, software version: 3. 16. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess). It was reported that pre-operatively, a manufacturer representative attempted to load a patient exam disc on the system as well as in the ear, nose & throat (ent) software on a different navigation system and received the message "unable to interpret header data". During troubleshooting, the disc loaded into the cranial software on a different navigation system without issue. The exam was exported from the cranial software, including the original digital intercommunication of medicine (dicom) images, and was imported into the original system. The original system software stated "no source image data found". The navigation portion of the surgery was rescheduled after incision and anesthesia due to the patient vital's dropping during the procedure. No other information was provided regarding patient. It was noted that the non-navigated portion of the procedure had been continue without navigation with no delay. It was suspected that the cause of the reported issue was compressed images.
 
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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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10810159
MDR Text Key215497860
Report Number1723170-2020-02932
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733560XOM
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
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

Patient Treatment Data
Date Received: 11/09/2020 Patient Sequence Number: 1
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