MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identification (udi) is unavailable.Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the emitter details displayed green status for both axiem and emitter but no instruments would track.Em interface had no faults bot when looked at the instruments that were tracking, bringing an instrument tracker into field generated a nav eer and all values would display as 0.When the trackers is removed from the field the emitter would show numbers as if it was tracking.There was no metal in the field.The emitter was not functioning and replacing the emitter resolved the issue.The system then passed the system checkout and was found to be fully functional.The emitter has not been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system being used during training.It was reported that the emitter was not working.The site was receiving connection issues.It was later reported that when the issue occurred, both the axiem box and the emitter had red status in the emitter details.The emitter was disconnected and reconnected and the issue temporarily resolved for a few minutes before occurring again.It was unknown if the emitter was disconnected by the site or by a representative, but disconnecting the emitter required the panel to be removed.There was no patient present when this issue was identified.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.The emitter was returned to the manufacturer for analysis.The emitter was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7592671
• MDR Text Key: 110847958
• Report Number: 1723170-2018-02722
• 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,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2015
• 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