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

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.

• Brand Name: FUSION ENT NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, 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 Key: 10810159
• MDR Text Key: 215497860
• Report Number: 1723170-2020-02932
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• 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 Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/20/2021
• 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