MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM; EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number FUSION COMPACT

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not available from the site.Patient age not available from the site.No parts were replaced or returned to the manufacturer for evaluation.The reported issue was resolved after a system reboot, and has not recurred, so no additional findings possible.

Event Description

A medtronic representative reported that during an ear, nose, and throat procedure, the navigation system suddenly entered a red status and no chirping sound could be heard.The system was restarted and the electomagnetic (em) control box was unplugged and re-connected, resolving the issue.The procedure was completed successfully with the navigation system after no delay.The patient was not impacted.

• Brand Name: MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
• Type of Device: EAR NOSE AND THROAT 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: 6121112
• MDR Text Key: 60692851
• Report Number: 1723170-2016-05495
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• 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: 11/22/2016

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
• Device Operator: Physician
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• 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
• Patient Weight: 77