MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRACKER 9733533XOM ENT INSTRUMENT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number	9733533XOM
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information from a manufacturer representative (rep) regarding a navigation instrument being used for a procedure.The rep indicated the first tracker wire was not even coming up on the screen.The rep indicated that they tried several times to get the tracker to work and tried plugging it into different ports.A different tracker was used to complete the procedure.There was no reported change in patient outcome or delay in procedure.
Additional Manufacturer Narrative
Additional information: patient demographics provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the navigation system was restarted without resolution during the procedure.There was a reported delay to the procedure of about ten minutes due to the reported issue.It was reported that the issue occurred in a functional endoscopic sinus surgery (fess), s, t and a polyp removal procedure.

• Brand Name: TRACKER 9733533XOM ENT INSTRUMENT
• Common Device Name: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8408529
• Report Number: 1723170-2019-01042
• Device Sequence Number: 16248325
• Product Code: PGW
• UDI-Device Identifier: 00613994380012
• UDI-Public: 00613994380012
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 09/24/2020
• Device Model Number: 9733533XOM
• Device Catalogue Number: 9733533XOM
• Device Lot Number: 180925C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 88