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

Model Number FUSION

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.A medtronic representative went to site to test the equipment.Representative was unable to replicate the reported issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced.No parts have been received by the manufacturer for evaluation.

Event Description

A site representative reported that while outside of procedure, the navigation system was turned on prior to a case but when the representative returned, the system was shut off.It was reported that the system was plugged in and the power switch was set to on.Turning the system off and powering in on, and unplugging/replugging the system did not resolve the issue.When the system was turned on later, it turned on without any issue.There was no patient present at the time of the issue.

Manufacturer Narrative

Additional information: device manufacture date provided.Correction: unique device identification (udi) updated to proper value.The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.The behavior of the reported issue was found to be consistent with a known anomaly in the medtronic navigation software anomaly tracking database.This issue was documented in a medtronic navigation software anomaly tracking database.

• 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: 7381443
• MDR Text Key: 103825400
• Report Number: 1723170-2018-01366
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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