MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	FUSION
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual product: balloon seeker 1830517frt em frnt 5x17mm.Device udi number and lot number unavailable.Device manufacturing date unavailable.A manufacture representative went to the site to test the equipment.Testing revealed that the system performed as intended.
Event or Problem Description
Medtronic received information intra-operatively during a functional endoscopic sinus surgery (fess).The ent rep called in with a surgeon on site during the procedure.It was reported that initially the frontal balloon was not recognized by the system when it was plugged into the axiem ports.The emitter details view showed nothing plugged into the port.It was swapped for a different balloon and the same issue occurred.It occurred on all ports of the system.No other instruments that were plugged into those ports at the time had any issue with tracking or navigating.The issue extended the surgical time by less than 1 hour.
Additional Manufacturer Narrative
Correction: product and related fields updated to proper value.
Additional Manufacturer Narrative
Additional information: medtronic received information that the surgeon opted to complete the procedure with an acclarent balloon and a medtronic micro debreeder instead of the medtronic balloon.There was no reported impact on patient outcome.No additional information was provided.

• Brand Name: FUSION NAVIGATION SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7770377
• Report Number: 1723170-2018-03934
• Device Sequence Number: 2348162
• Product Code: HAW
• UDI-Device Identifier: 00643169770942
• UDI-Public: 00643169770942
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2018

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: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 09/14/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 08/29/2018; 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 49