BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11936106 · Received June 3, 2021

    Report

    Report Number
    3010676138-2021-00109
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 3, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020464
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFECTION WAS NOT PRESENT AND THE IMPLANTING CLINICIAN IDENTIFIED THE PATIENT WAS EXPERIENCING IRRITATION FROM A SUTURE THAT WAS STILL IN THE SKIN. THE IMPLANTING CLINICIAN REMOVED THE SUTURE AND STATED A REVISION/EXPLANT WAS NOT NECESSARY. THE CLINICAL REPRESENTATIVE FOLLOWED UP ON THE PATIENT'S CONDITION AND REPORTED THE PATIENT IS FEELING FINE. THE SURGICAL ISSUE QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, PATIENT ENGAGING IN STRENUOUS ACTIVITIES, IMPLANTING A NON-STERILE DEVICE, IMPLANTING AN EXPIRED DEVICE, NOT IRRIGATING THE INCISION SITE, NOT USING ANTIBIOTICS, NOT PREPPING THE SKIN, USING INAPPROPRIATE TOOLS, PATIENT PICKING AT THE WOUND AND MULTIPLE TUNNELING ATTEMPTS HAVE BEEN RULED OUT AS POTENTIAL CAUSES. 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 FOR THE TREATMENT OF PAIN. THE CAUSE OF THE IRRITATION IS NO FAULT FOUND AS RELATED TO THE DEVICE; THE IRRITATION WAS CAUSED BY THE SUTURES USED.

    Description of Event or Problem · 1

    PATIENT'S SUTURE SITE WAS IRRITATED AND ITCHY. THE PATIENT HAD AN IRRITATION FROM A SUTURE ON THE SKIN. THE SUTURE WAS REMOVED, AND NO FURTHER ISSUE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831870 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0 SWO201025 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention