MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Mechanical Problem (1384)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6). A medtronic representative went to the site to test the equipment. Testing revealed that the system becomes unresponsive. The re presentative replaced the axiem box and the external cable. The system then passed the system checkout and was found to be fully functional. No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used during a procedure. It was reported that the system operated without problems until the site came to the registration and the instrument could not be used. The system froze after a certain period of time after. The site was able to proceed with the case by restarting the navigation system. It is if there was any delay to the procedure and patient outcome is unknown.

Manufacturer Narrative

Additional information: no patient involvement. Analysis on the returned axiem box resulted in no failure being found through functional testing and visual/physical examination. Analysis states that upon initial connection, all eight ports were tracking. The device remained fully functional throughout the entire duration of testing. If information is provided in the future, a supplemental report will be issued.

Event Description

It was confirmed that this issue occurred outside of procedure and no patients were involved.

Manufacturer Narrative

Correction: the date received by manufacturer was 02/04/2019 on the followup1 (1723170-2018-06169) mdr submission. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis on the returned axiem communication cable resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the cable was found to be in good condition and was fully functional when connected to a known good system. If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• Type of Device: EAR, 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8147779
• Report Number: 1723170-2018-06169
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Device Lot Number: 2062136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown