MAUDE Adverse Event Report: MEDTRONIC NAVIGATION ISRAEL, LTD POLESTAR N30 SURGICAL MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 9734070

Device Problem Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.Manufacture date was not available on the date of filing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system.It was reported that intra/peri-operatively during the select patient/acquire scans task of a cranial resection, the image quality was so bad that the site could not use the system.There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.

Manufacturer Narrative

Follow up for this issue is documented in regulatory report 1723170-2019-00745.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was concluded that the high noise and low signal were caused by operator mistake.The procedure was completed without the imaging system.

• Brand Name: POLESTAR N30 SURGICAL MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION ISRAEL, LTD; 3 hacarmel street p.o. box 548; kochav yokneam building; yokneam elit ha zafon
• Manufacturer (Section G): MEDTRONIC NAVIGATION ISRAEL, LTD; 3 hacarmel street p.o. box 548; kochav yokneam building; yokneam elit ha zafon
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8401440
• MDR Text Key: 138158266
• Report Number: 9710108-2019-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734070
• Device Catalogue Number: 9734070
• Device Lot Number: WO081102440190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 60 YR
• Patient Weight: 70