MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) POLESTAR; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 9734070

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A manufacturer representative went to the site to test the imaging system.The reported issue was confirmed the umbilical assembly was replaced.A system checkout was performed and the system is working as intended.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 outside of a procedure that the system was stuck in initializing please wait.The site had performed multiple reboots with no resolution.The site was unwilling to remote into the image acquisition system (ias) computer over the phone.No patient was present at the time of the event.

• Brand Name: POLESTAR
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8305863
• MDR Text Key: 135033013
• Report Number: 3004785967-2019-00194
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2009
• 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