BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMWAVE STQ4

    MDR report key: 18418260 · Received December 28, 2023

    Report

    Report Number
    MW5149659
    Event Type
    Injury
    Date Received
    December 28, 2023
    Date of Event
    December 21, 2023
    Report Date
    December 26, 2023
    Manufacturer
    STIMWAVE/CURONIX LLC
    Product Code
    GZF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SAW ON THE NEWS THAT STIMWAVE HAS FILED FOR BANKRUPTCY IN 2022 AND THE CEO WAS ARRESTED FOR VARIOUS TYPES OF FRAUD, I.E. INSURANCE ETC. ALL STIMWAVE DEVICES BASED ON MY OWN RESEARCH HAS SHOWN THAT MY PARTICULAR DEVICE IS ON THE FDA RECALL LIST. THE DEVICE NEVER REALLY WORKED TO RELIEVE MY PAIN. I REACHED OUT TO THE COMPANY THAT HAS TAKEN OVER FOR STIMWAVE ON 12/26/2013 AND THEY HAVE MY FILE AND THEY ARE WORKING ON HAVING SOMEONE CONTACT ME WITH FURTHER GUIDANCE REGARDING THIS MATTER. REFERENCE REPORT: #MW5149658.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017679 STIMWAVE STQ4 STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) GZF STIMWAVE/CURONIX LLC STQ4-SPR-B0

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention COMBIVENT.| DEXILANT.| DULERA. | EFFEXOR.| FAMOTIDINE.| FINASTERIDE.| LATANOPROST.| LINZESS.| PREGABALIN.| PROPRANOLOL.| RESPIMAT.| STIMWAVE.| TRAZODONE.