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

Model Number 9733560XOM

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9733320r pend, serial/lot #: unknown, udi#: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the system displayed an axiem box communication error.The rep checked the number being displayed on the axiem box and it was an 8.The axiem box was to be replace.There was no patient present when this issue was identified.

Manufacturer Narrative

Other relevant device(s) are: product id: 9733405, serial/lot #: unknown.A medtronic representative went to the site to troubleshoot.It was noted that wiggling the pc communication cable on the axiem box caused the axiem code to go between 8 <(>&<)> 7.The system 9733320 axiem integrated 4 port (lot# 0200065248) was returned for analysis.Analysis found that all ports were tracking normal.The unit was left connected to a test system in excess of twenty four hours and no issues were observed, as tracking remained consistent throughout the duration of testing.No failure was found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The manufacture representative documented the system checkout.The cable replacement was documented.The issue resolved.If information is provided in the future, a supplemental report will be issued.

• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9353942
• MDR Text Key: 178346977
• Report Number: 1723170-2019-05704
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Date Manufacturer Received: 01/04/2020
• 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 Sequence Number: 1