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

Model Number	9734887XOM
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient tracker was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.When the tracker was connected to a known good system the tracker displayed red status only, not tracking.A check of the em interface showed that coils #1 and #2 were dead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that the site was using a patient tracker they verified the instrument, registered, and then when they got to navigate, the tracker showed red status.They moved the emitter, checked for metal, all with no resolution.They rebooted the system still without resolution.At this point, they placed a new patient tracker on, verified instruments, registered, and went to navigate without issue.Nothing else had changed in the environment.There was less than an hour delay in the procedure.No impact on patient outcome.

• Brand Name: FUSION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8468945
• Report Number: 1723170-2019-01456
• Device Sequence Number: 1784448
• Product Code: HAW
• UDI-Device Identifier: 00643169488120
• UDI-Public: 00643169488120
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2022
• Device Model Number: 9734887XOM
• Device Catalogue Number: 9734887XOM
• Device Lot Number: 190103A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 130