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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (ISRAEL) SYS 9734070R POLESTAR N30 REWORK SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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.
 
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Brand NameSYS 9734070R POLESTAR N30 REWORK
Type of DeviceSYSTEM, 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 Key7889628
MDR Text Key120731350
Report Number1723170-2018-04813
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
PMA/PMN Number
K092308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPOLESTAR
Device Catalogue Number9734070R
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2016
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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