MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INSTRUMENT TRACKER, EM ENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733533
Medical Device Problem Codes	Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect em tracker.No parts have been received by manufacturer for analysis.Part not received by manufacturer.
Event or Problem Description
A medtronic representative reported that, while in a procedure, their em tracker experienced a recognition failure.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon opted to discontinue the use of the navigation system to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome reported.
Additional Manufacturer Narrative
Additional information: a medtronic representative reported that according to the rep the tracker was able to be recognized after the report event.The site declined to return the device, and the lot number was unobtainable.The doctor refused to provide patient information.

• Brand Name: INSTRUMENT TRACKER, EM ENT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6177416
• Report Number: 1723170-2016-05773
• Device Sequence Number: 914697
• Product Code: HAW
• UDI-Device Identifier: 00613994353450
• UDI-Public: 00613994353450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001284
• 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,Followup
• Report Date (Section B): 01/12/2017

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 Catalogue Number: 9733533
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1