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

Model Number 9733560XOM

Device Problems Communication or Transmission Problem (2896); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

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. It was reported that while loading a patient disc the system became un responsive. When the exams did load, the exams did not fully, and it appeared that the system went unresponsive and did not fully load the scan. This issue was noted outside of a procedure, and there was no patient involvement.

• 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: 11089973
• MDR Text Key: 224540163
• Report Number: 1723170-2020-03427
• 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
• Report Date: 12/29/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/18/2020
• 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