MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (ISRAEL) SYS 9734070R POLESTAR N30 REWORK; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number POLESTAR

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier (udi) is unavailable.A medtronic representative went to the site to cover a subsequent tissue ablation procedure.It was noted that the reported event recurred and that the monitor was not mri compatible.The representative then disconnected the starshild cable from the patient monitor and the reported issue was resolved.

Event Description

Medtronic received information that, while outside of a procedure, the image acquisitions on the system were not visible.It was noted that the images only contained "noise".There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Part number and associate fields updated.Unique device identification(udi) and manufacture date provided.

• Brand Name: SYS 9734070R POLESTAR N30 REWORK
• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7889628
• MDR Text Key: 120731350
• Report Number: 1723170-2018-04813
• 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
• Report Date: 09/21/2018

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
• Device Operator: Health Professional
• Device Model Number: POLESTAR
• Device Catalogue Number: 9734070R
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2016
• 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