NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CM C-1005-S

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 2019-11-19 for NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CM C-1005-S manufactured by St. Jude Medical, Inc..

MAUDE Entry Details

Report Number2182269-2019-00212
MDR Report Key9343587
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-19
Date of Report2019-11-19
Date of Event2019-07-22
Date Mfgr Received2019-10-31
Device Manufacturer Date2019-02-25
Date Added to Maude2019-11-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Street14901 DEVEAU PLACE
Manufacturer CityMINNETONKA MN 55345
Manufacturer CountryUS
Manufacturer Postal Code55345
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberFA-Q419-NM_EP-2
Event Type3
Type of Report3

Device Details

Brand NameNEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CM
Generic NameRF CANNULA
Product CodeGXI
Date Received2019-11-19
Model NumberC-1005-S
Lot Number6865795
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.
Manufacturer Address14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.