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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC (LITTLETON) POLESTAR SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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.
 
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Brand NamePOLESTAR
Type of DeviceSYSTEM, 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 Key8305863
MDR Text Key135033013
Report Number3004785967-2019-00194
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092308
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734070
Device Catalogue Number9734070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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