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

Model Number	FUSION
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier weight not available from the site.No procode and device lot number unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number, therefore, unavailable.
Event or Problem Description
Medtronic received information that, during a functional endoscopic sinus surgery (fess) procedure, the sphenoid balloon was imprecise.All other instruments used during the procedure were accurate.After getting visual confirmation and checking the accuracy with a suction, the surgeon ballooned the sphenoid sinus.There was a reported delay of a few minutes.No known impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
Correction: product and related fields updated to proper value.Corrected as the original product is not manufactured by medtronic navigation, inc.A medtronic representative went to the site to test the equipment.Testing revealed that the representative was unable to replicate the reported issue.The system then passed the system checkout and was found to be fully functional.The balloon seeker was returned to the manufacturer for evaluation.Testing found that the balloon seeker was bent at the tip and not able to pass verification.
Additional Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided.Correction: product and related fields updated to proper value.

• 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: 7527885
• Report Number: 1723170-2018-02134
• Device Sequence Number: 1698162
• Product Code: HAW
• UDI-Device Identifier: 00643169770980
• UDI-Public: 00643169770980
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2018

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: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 05/15/2018; 07/25/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/12/2018; 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR