MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM; EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number FUSION COMPACT

Device Problems Computer Software Problem (1112); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2017

Event Type  malfunction  

Manufacturer Narrative

On 02/18/2017, a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A site registered nurse (rn) reported that, while in an ear, nose & throat (ent) procedure, their navigation system was acting slow on multiple pages: in patient import page and in registration page.Noted was difficulty in verifying the probe.No further details regarding this issue were provided.The surgeon opted to complete the procedure without the use of the navigation system.Delay in therapy was greater than one hour before continuing.There was no impact on patient outcome.

Manufacturer Narrative

Medtronic personnel reported that the instrument the site was attempting to verify was outside of the emitter field.The site has been instructed on proper emitter placement.The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.

• Brand Name: MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
• Type of Device: EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6342591
• MDR Text Key: 67867053
• Report Number: 1723170-2017-00745
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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
• Patient Age: 35 YR
• Patient Weight: 65