4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-30 for 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by Neurotherm, Inc.

Event Text Entries

[181617310] The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.?
Patient Sequence No: 1, Text Type: N, H10


[181617311] During a pulsed radiofrequency nerve block procedure, the generator shut down and the procedure was cancelled. When attempting to reboot, the generator would not complete the boot up sequence and would continue to shut down. The procedure was rescheduled for a later date. There were no adverse consequences to the patient due to the cancellation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002953813-2020-00006
MDR Report Key9646702
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-30
Date of Report2020-01-30
Date of Event2020-01-27
Date Mfgr Received2020-01-28
Date Added to Maude2020-01-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1NEUROTHERM, INC
Manufacturer Street600 RESEARCH DRIVE STE 1
Manufacturer CityWILMINGTON MA 01887
Manufacturer CountryUS
Manufacturer Postal Code01887
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR
Generic NameGENERATOR, LESION, RADIOFREQUENCY
Product CodeGXD
Date Received2020-01-30
Model NumberRFG-NT-2000
Catalog NumberRFG-NT-2000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNEUROTHERM, INC
Manufacturer Address600 RESEARCH DRIVE STE 1 WILMINGTON MA 01887 US 01887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-30

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