MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PATIENT TRACKER 9734887XOM NON-INVASIVE; INSTRUMENT, STEREOTAXIC

Model Number	9734887XOM
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.The patient tracker was returned for analysis.Functional testing found that there was a dead coil causing the issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that the instrument would not verify.The site used a new instrument and proceeded with the case.There was no reported delay to procedure and no reported impact to patient outcome.

• Brand Name: PATIENT TRACKER 9734887XOM NON-INVASIVE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8519203
• Report Number: 1723170-2019-01775
• Device Sequence Number: 13914864
• Product Code: HAW
• UDI-Device Identifier: 00643169488120
• UDI-Public: 00643169488120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 10/18/2021
• Device Model Number: 9734887XOM
• Device Catalogue Number: 9734887XOM
• Device Lot Number: 181019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1