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

Model Number	POLESTAR
Medical Device Problem Codes	Device Inoperable (1663); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to site to test the equipment.Representative reported that the main switch for the rf amplifier was off.Switching on the main switch resolved the signal issue but the error message still persists.No parts were replaced.No parts have been received by manufacturer for evaluation.
Event or Problem Description
A site representative reported that during a cranial resection procedure, the site was unable to perform any scans with the imaging system and the coil signal is zero on both sides.After restarting the system, an error in rf-amplifier communication, error message was displayed.Calibrating the system did not resolve the issue.The procedure was completed without the use of imaging.There was a delay of less than 1 hour.No information was provided on patient outcome.

• Brand Name: POLESTAR N30 SURGICAL MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (ISRAEL); p.o. box 548; kochav yokneam bldg.; yokneam elit 20692 ; IS 20692
• MDR Report Key: 6868992
• Report Number: 1723170-2017-03759
• Device Sequence Number: 10965036
• Product Code: LNH
• UDI-Device Identifier: 00613994719225
• UDI-Public: 00613994719225
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Radiologic Technologist
• Device Model Number: POLESTAR
• Device Catalogue Number: 9734070
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 70