MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9733447XOM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer representative went to the site to test the navigation system.The reported issue could not be confirmed and not parts were replaced.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a cranial resection.It was reported that the site was having issues with tracking the passive planar instrument only.There were no issues with any other instruments.There was a 10 minute delay before the sit decided to abort navigation.No impact on patient outcome.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8691752
• Report Number: 1723170-2019-03230
• Device Sequence Number: 2016467
• Product Code: HAW
• UDI-Device Identifier: 00613994306821
• UDI-Public: 00613994306821
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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 Model Number: 9733447XOM
• Device Catalogue Number: 9733447XOM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 113