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 Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

A site representative reported that, while outside of a procedure, the navigation system did not respond to prompt from the user.It was noted that an error message appeared stating that the api to gantry motion controller was not operating as designed.A site biomedical engineer was reported to have checked the connections and indicators on the navigation system without resolution.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Additional information: device manufacture date provided.Correction: unique device identification (udi) updated to proper value.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was found that suspected system components are either the s.P.S.Or the motion controller.Replacement of the component has not been performed as the site has not provided confirmation to medtronic to perform the replacement.

• 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7385439
• MDR Text Key: 103963303
• Report Number: 1723170-2018-01403
• Device Sequence Number: 1
• Product Code: LNH
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• 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: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2013
• 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