MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PATIENT TRACKER 9734887XOM NON-INVASIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9734887XOM
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument tracker and patient tracker were both received by the manufacturer for evaluation.Instrument tracker reported problem could not be duplicated.The instrument tracker was connected to a test system and the system remained in green status with no failures.Patient tracker reported problem was confirmed.Test system reported the patient tracker as an unknown instrument.See photos in the attachments.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.The trackers were replaced and the issue was resolved.
Event or Problem Description
A medtronic representative reported that during an ear, nose, and throat procedure, a suction instrument was unable to be recognized by the navigation system.It was reported that registration was successfully completed, but when the surgeon attempted to use the straight suction instrument with an instrument tracker, the software did not recognize it.The emitter position was adjusted and the system was rebooted, neither of which resolved the issue.The surgeon opted to complete the procedure without the use of the navigation system.The procedure was completed successfully and the patient was not impacted.

• Brand Name: PATIENT TRACKER 9734887XOM NON-INVASIVE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6206978
• Report Number: 1723170-2016-05942
• Device Sequence Number: 1070647
• Product Code: HAW
• UDI-Device Identifier: 00643169488120
• UDI-Public: 00643169488120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/27/2016

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 Expiration Date: 07/18/2019
• Device Catalogue Number: 9734887XOM
• Device Lot Number: 160718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1