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

Model Number FUSION

Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to (b)(6) patient privacy regulations.Preliminary analysis of the tracer pattern registered showed that the pattern focused on the nose and a line on the forehead of the patient.Accuracy would likely have improved if the pattern encompassed more of the temples and top of the head.The investigation into the root cause of the inaccuracy is currently ongoing.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A medtronic representative reported that, while in a procedure, an inaccuracy was found when using the navigation system.No additional information was provided.The length of delay to the procedure and impact on the patient were not provided by the site.

Manufacturer Narrative

A medtronic representative, following up with the site, reported that the inaccuracy was less than 2mm related to straight suction (all other instruments worked within tolerances).The monitors were moved and it was reported that there was better success with instruments not being recognized.The medtronic representative reported the procedure continued with inaccuracy noted.The software investigation found that the reported event was unrelated to a software issue.The completed tracer pattern focused on the nose and a line on the forehead.The software functioned as designed.The instructions for use (ifu) that accompanies the device provides guidance for multiple registration methods.

• Brand Name: SYSTEM FUSION EM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6196541
• MDR Text Key: 63068350
• Report Number: 1723170-2016-05759
• Device Sequence Number: 1
• Product Code: HAW
• 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: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2013
• 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