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

Model Number FUSION

Device Problems No Display/Image (1183); Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.Issue resolved at time of trouble-shooting.

Event Description

A medtronic representative received a report from a site that their navigation system experienced a no input detected issue.The site stated that their navigation system shows "no input detected" as proceeding the screen after it turned to black.The screen would displaying this message 10 minutes or more before the site can change it to next patient's image.The site representative noted there were no loose cables and also stated that "no input detected" showed up as they were shutting-down, and did not complete shut down process.No further details regarding the behavior were provided.In trouble-shooting, the medtronic representative was able to get out of no input detected by turning the screen off/on.There was no patient present when this issue was identified.

Manufacturer Narrative

Correction: product and unique device identification (udi) updated to proper value.

• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6584333
• MDR Text Key: 75776778
• Report Number: 1723170-2017-02099
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K001284
• 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,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION
• Device Catalogue Number: 9733560
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2009
• 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