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

Model Number POLESTAR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.During the onsite inspection, the medtronic representative reported that the emergency button on the left side of the scanner had been switched on.The medtronic representative unlocked the system which resolved the issue.After the system started up, it was re-homed.The system was found to be fully functional after this.

Event Description

A site representative reported that the tool had been blocked by the scanner.The site used the manual open procedure to open it and then attempted to restart the system, but it would not startup.No patient was present during the time of the reported incident.

• 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: jasmine birlew ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6432046
• MDR Text Key: 70809522
• Report Number: 1723170-2017-01323
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00613994719225
• UDI-Public: 00613994719225
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K092308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• 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: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2010
• 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