STIMQ NEUROSTIMULATOR STQ4-RCV-A0; STQ4-SPR-B0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-19 for STIMQ NEUROSTIMULATOR STQ4-RCV-A0; STQ4-SPR-B0 manufactured by Stimwave Technologies Inc..

MAUDE Entry Details

Report Number3010676138-2020-00028
MDR Report Key9857948
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-19
Date of Report2020-03-02
Date of Event2019-12-31
Date Mfgr Received2019-12-31
Device Manufacturer Date2018-09-13
Date Added to Maude2020-03-19
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 ContactMRS. MARY ANN GREENAWALT
Manufacturer Street1310 PARK CENTRAL BOULEVARD S.
Manufacturer CityPOMPANO BEACH,
Manufacturer CountryUS
Manufacturer G1STIMWAVE TECHNOLOGIES INC.
Manufacturer Street1310 PARK CENTRAL BOULEVARD S.
Manufacturer CityPOMPANO BEACH,
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTIMQ NEUROSTIMULATOR
Generic NamePERIPHERAL NERVE STIMULATOR
Product CodeGZF
Date Received2020-03-19
Model NumberSTQ4-RCV-A0; STQ4-SPR-B0
Lot NumberSWO190414; SWO190423
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTIMWAVE TECHNOLOGIES INC.
Manufacturer Address1310 PARK CENTRAL BOULEVARD S. POMPANO BEACH, US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-19

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