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

Model Number FUSION

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to site to test the equipment.Representative reported that a computer was replaced to resolve the issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect computer has been received by the manufacturer for evaluation.The returned computer was tested and computer passed all tests without any errors.No fault found.

Event Description

A medtronic representative reported that during functional endoscopic sinus surgery (fess), the navigation system unexpectedly shutdown.The procedure was completed with the use of navigation.No information was provided on delay to procedure and patient outcome.

Manufacturer Narrative

Correction: device manufacture dated corrected.

Manufacturer Narrative

Additional information: the patient demographic information was requested from (b)(6) coordinator on (b)(6) 2019 at the facility indicated the information was unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system during a functional endoscopic sinus surgery (fess).It was reported that in the middle of the case the system unexpectedly shutdown.The surgery was completed with unknown amount of delay nor unknown patient impact.

• 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: pa chia vue ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7379693
• MDR Text Key: 103786619
• Report Number: 1723170-2018-01363
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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: 03/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2012
• 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