STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM FR8A-RCV-A0; FR8A-TRL-B0

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 2019-10-21 for STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM FR8A-RCV-A0; FR8A-TRL-B0 manufactured by Stimwave Technologies Inc..

MAUDE Entry Details

Report Number3010676138-2019-00037
MDR Report Key9213683
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-21
Date of Report2019-10-21
Date of Event2019-09-13
Date Mfgr Received2019-09-23
Device Manufacturer Date2018-03-02
Date Added to Maude2019-10-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS ELIZABETH GREENE
Manufacturer Street1310 PARK CENTRAL BOULEVARD S.
Manufacturer CityPOMPANO BEACH FL 33064
Manufacturer CountryUS
Manufacturer Postal33064
Manufacturer Phone8009655134
Manufacturer G1STIMWAVE TECHNOLOGIES INC.
Manufacturer Street1310 PARK CENTRAL BOULEVARD S.
Manufacturer CityPOMPANO BEACH FL 33064
Manufacturer CountryUS
Manufacturer Postal Code33064
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
Generic NamePERIPHERAL NERVE STIMULATOR
Product CodeGZF
Date Received2019-10-21
Model NumberFR8A-RCV-A0; FR8A-TRL-B0
Lot NumberSWO180404; SWO180404
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTIMWAVE TECHNOLOGIES INC.
Manufacturer Address1310 PARK CENTRAL BOULEVARD S. POMPANO BEACH FL 33064 US 33064


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-21

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