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 Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information that, while outside of a procedure, it was identified the navigation system failed after installation.The screen turned black and a blank white screen appeared.The system was not shutting down and had to be "forcefully" shut down.Troubleshooting was performed and all connections were removed.The system was reconnected but the system continued to display the white screen.There was no response.

• 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: pa chia vue ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7525275
• MDR Text Key: 108623503
• Report Number: 1723170-2018-02124
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/18/2018

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
• Device Operator: Health Professional
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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