MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (ISRAEL) POLESTAR N30 SURGICAL MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number POLESTAR

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.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 site representative reported that, while in a cranial resection, the magnetic resonance imaging (mri) image acquisition discontinued without prompt from the user.The surgeon opted to complete the procedure without the use of the navigation system.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the issue.System function as expected.

Manufacturer Narrative

The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and the 'scan' indication lamp (outside of the room) was not working.Opening the operating room (or) door during the scan, due to lack of indication, might cause image artifacts.The site is responsible to fix the 'scan' indication lamp.The msc door mechanic lock was not working.The site is responsible to fixing the door lock.The magnet out indication lamp (outside of the room) was not working.The site is responsible for fixing the lamp.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLESTAR N30 SURGICAL MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (ISRAEL); p.o. box 548; kochav yokneam bldg.; yokneam elit 20692 ; IS 20692
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (ISRAEL); p.o. box 548; kochav yokneam bldg.; yokneam elit 20692 ; IS 20692
• Manufacturer Contact: koko tyler ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208903200
• MDR Report Key: 7296614
• MDR Text Key: 101020524
• Report Number: 1723170-2018-00849
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00613994719225
• UDI-Public: 00613994719225
• Combination Product (y/n): N
• PMA/PMN Number: K092308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: POLESTAR
• Device Catalogue Number: 9734070
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• 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