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 2020-01-17 for 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by St. Jude Medical, Inc..

Event Text Entries

[175378218] 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


[175378219] During a simplicity procedure, the generator would not reach temperature and the procedure was delayed. The cables were replaced with no resolution. The lesion setting was changed from monopolar to dual polar and the target temperature was reached. The procedure was delayed by 50 minutes and the patient became uncomfortable while laying down due to the procedure delay however the procedure was completed successfully with no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2184149-2020-00006
MDR Report Key9601330
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-17
Date of Report2020-02-28
Date of Event2020-01-03
Date Mfgr Received2020-02-20
Device Manufacturer Date2016-08-16
Date Added to Maude2020-01-17
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 G1ST. JUDE MEDICAL, INC.
Manufacturer StreetONE ST. JUDE MEDICAL DRIVE
Manufacturer CityST. PAUL MN 55117
Manufacturer CountryUS
Manufacturer Postal Code55117
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 Received2020-01-17
Returned To Mfg2020-01-27
Model NumberRFG-NT-2000
Catalog NumberRFG-NT-2000
Lot Number5599098
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.
Manufacturer AddressONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-17

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