BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11898847 · Received May 27, 2021

    Report

    Report Number
    3010676138-2021-00103
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 27, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRIAL LEADS WERE EXPLANTED (UNKNOWN DATE), THE TEGADERM WAS REMOVED AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE IMPLANTING CLINICIAN'S OFFICE EXPLAINED THERE WAS NOT A RASH PRESENT AT THE INCISION SITE. THE IRRITATION WAS PRESENT WHERE THE TEGADERM WAS PLACED ON THE SKIN. THE IMPLANTING CLINICIAN REMOVED THE TRIAL LEADS (DATE UNKNOWN) AND THE IMPLANTING CLINICIAN AND WILL MOVE FORWARD WITH A PERMANENT IMPLANT. THE PATIENT DISCLOSED TO THE CLINICAL REPRESENTATIVE THAT AFTER REMOVING THE LEADS AND TAKING THE TEGADERM OFF THE IRRITATION CLEARED OUT. THE IMPLANTING CLINICIAN STATED THE PATIENT WAS HAVING A REACTION TO THAT TEGADERM. A STIMWAVE REPRESENTATIVE CONDUCTED A REVIEW OF STERILIZATION AND PACKAGING RECORDS FOR THE RESPECTIVE PRODUCT LOT; STIMWAVE HAS CONFIRMED THAT THE PRODUCT WAS DELIVERED STERILE, VALIDATED STERILIZATION PARAMETERS WERE USED, AND STERILE BARRIERS WERE VERIFIED TO BE INTACT FOLLOWING PACKAGING. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE ERYTHEMA IS NO FAULT FOUND IN REGARDS TO THE STIMWAVE DEVICE; THE IRRITATION IS BELIEVED TO BE DUE TO THE TEGADERM.

    Description of Event or Problem · 1

    THE IMPLANTING CLINICIAN'S OFFICE EXPLAINED THERE WAS NOT A RASH PRESENT AT THE INCISION SITE. THE IRRITATION WAS PRESENT WHERE THE TEGADERM WAS PLACED ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792762 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. FR4A-TRL-A0, FR4A-TRL-B0 SWO210216A, SWO210216

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention