MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INSTRUMENT TRACKER, EM ENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733533
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age not available from the site.Lot no.And manufacture date not available for this instrument at time of filing.A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were returned to the manufacturer for evaluation.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.The issue occurred intraoperatively while verifying instruments and caused a delay of 5 minutes to the surgery.It was reported that the site had a bad instrument tracker.The surgeon completed the case without navigation and there was no impact on patient outcome.
Additional Manufacturer Narrative
Review of this event and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.

• Brand Name: INSTRUMENT TRACKER, EM ENT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7569419
• Report Number: 1723170-2018-02517
• Device Sequence Number: 16444289
• Product Code: HAW
• UDI-Device Identifier: 00643169702837
• UDI-Public: 00643169702837
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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
• Operator of Device: Physician
• Device Catalogue Number: 9733533
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 79