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,health report with the FDA on 2020-02-07 for 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by St. Jude Medical, Inc..

Event Text Entries

[178218938] During a lumbar ablation procedure, the generator would not increase temperature and the procedure was cancelled. The probes would not exceed 37 degrees so stagger start was attempted, a different adapter was used, and the grounding pad was replaced with no resolution. Impedance remained between 200-400 ohms. The probes were reading temperature but would not increase in temperature when auto start was pressed and the procedure was rescheduled. There were no adverse consequences to the patient due to the cancellation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2184149-2020-00008
MDR Report Key9683628
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-07
Date of Report2020-02-07
Date of Event2020-01-13
Date Mfgr Received2020-01-13
Device Manufacturer Date2019-11-11
Date Added to Maude2020-02-07
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 Received2020-02-07
Returned To Mfg2020-02-06
Model NumberRFG-NT-2000
Catalog NumberRFG-NT-2000
Lot Number7248337
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
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 2020-02-07

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