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

Catalog Number	9734887
Medical Device Problem Codes	Device Inoperable (1663); Communication or Transmission Problem (2896); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The site dr.(b)(6) declined to provide patient information.Return requested for suspect non-invasive patient tracker.No parts have been received by manufacturer for analysis.
Event or Problem Description
A medtronic representative reported that while in an ear, nose & throat (ent) procedure, the site had a damaged patient tracker with verification issues.The patient tracker was working the suddenly became unverified.This occurred during active navigation.The damaged patient tracker was replaced with a back-up instrument and the procedure continued.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

• Brand Name: PATIENT TRACKER 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: 6562323
• Report Number: 1723170-2017-01975
• Device Sequence Number: 1170462
• Product Code: HAW
• UDI-Device Identifier: 00643169488113
• UDI-Public: 00643169488113
• 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): 05/11/2017

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: 07/28/2019
• Device Catalogue Number: 9734887
• Device Lot Number: 160728D
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1