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

Model Number FUSION

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative inspected the imaging system on-site.The electromagnetic (em) control box and field generator were replaced and received by the manufacturer for evaluation.Analysis of the field generator could not duplicate the reported problem.The field generator was connected to a test system for an overnight burn-in test.The system remained in green status during all testing.It passed the accuracy test with an error of 1.806mm.Flexing the cable does not indicate any intermittent opens.Fully functional.Analysis of the box was similarly unable to duplicate the issue.The unit was connected to a test system with the ear, nose, and throat (ent) application for a burn-in test.Registration, tracking, and accuracy looked normal on all 4 tool ports.It passed the accuracy test with an error of 1.887mm.Connected / disconnected the tools from each port and system remained functional.Despite both parts being found fully functional, replacement of these parts resolved the issue.A full navigation system check-out was completed following part replacement and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A medtronic representative reported that during an ear, nose, and throat procedure, the navigation system was 2mm inaccurate.The navigation system was still able to be used to successfully complete the procedure, and the patient was not impacted.No further details were provided.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: nicholas mcnabb ; 826 coal creek circle; louisville, CO 80027 ; 7208902439
• MDR Report Key: 6125230
• MDR Text Key: 60877122
• Report Number: 1723170-2016-05528
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1