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

Model Number	9734887XOM
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/05/2018
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 system outside of a procedure.The contact reported that the site was having issues with a patient tracker being unable to track.The contact indicated that the issue was noticed on december 05, 2018, but the site did not report the issue to the rep until april 25, 2019.There was no patient involved with this issue.

• Brand Name: PATIENT TRACKER NON-INVASIVE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8564755
• Report Number: 1723170-2019-02042
• Device Sequence Number: 2065676
• Product Code: HAW
• UDI-Device Identifier: 00643169488120
• UDI-Public: 00643169488120
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 09/14/2021
• Device Model Number: 9734887XOM
• Device Catalogue Number: 9734887XOM
• Device Lot Number: 180915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1