BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11634122 · Received April 8, 2021

    Report

    Report Number
    3010676138-2021-00062
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 9, 2021
    Report Date
    March 9, 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 PATIENT WAS IN A PRONE POSITION WHICH MADE IT DIFFICULT FOR THE NURSE TO MAINTAIN THE AIRWAY OPEN. THE NURSE ATTEMPTED TO ACCESS THE PATIENT UNDER THE STERILE FIELD TO CREATE AN AIRWAY BUT WAS UNSUCCESSFUL. THE IMPLANTING CLINICIAN REMOVED THE INTRODUCER. THE PROCEDURE WAS CANCELED, AND ATTENTION WAS TURNED TO THE PATIENT TO HELP STABILIZE HIS DECREASING VITALS. THE PATIENT WAS STABILIZED IN THE ER AND TRANSPORTED TO THE POST-ANESTHESIA CARE UNIT. THE IMPLANTING CLINICIAN DISCLOSED TO THE CLINICAL REPRESENTATIVE THAT THE PATIENT HAS SEVERAL HEALTH CONDITIONS AND HAD COVID-19 WHICH MAY HAVE CONTRIBUTED TO THE OCCURRENCE; THE PATIENT IS ALSO OVERWEIGHT. DURING THE PROCEDURE, HE WAS PLACED IN A PRONE POSITION THAT MAY HAVE CAUSED THE AIRWAY ISSUES. THE CLINICAL REPRESENTATIVE DISCLOSED THAT THE STIMULATOR PACKAGE KITS WERE OPENED AND NOT IMPLANTED DUE TO THE PATIENT VITALS DECLINING. 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. BASED ON THIS INFORMATION, THE PATIENT VITALS DECLINING WAS CONFIRMED/REPLICATED THERE IS NO EVIDENCE THAT PRODUCT DID NOT MEET SPECIFICATION AND THE STIMULATOR IS USED FOR TREATMENT OF PAIN. THE CAUSE OF THE PATIENT'S VITALS DECLINING DUE TO USER ERROR UNRELATED TO PRODUCT BY THE MEDICAL STAFF. THIS IS THE THIRD OCCURRENCE OF THIS TYPE OF EVENT AND IS UNRELATED TO STIMWAVE PRODUCT OR STIMWAVE PROCEDURE. MDRS ARE TRACKED AND TRENDED AS PART OF MANAGEMENT REVIEW. BASED ON THIS, CAPA/RESOLUTION IS NOT REQUIRED. STIMWAVE'S GLOBAL CODED RATE: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CLINICAL REPRESENTATIVE WAS PRESENT AT AN IMPLANT PROCEDURE. THE IMPLANTING CLINICIAN CREATED THE INCISION AND INSERTED THE YELLOW INTRODUCER. THE NURSE INFORMED THE IMPLANTING CLINICIAN THAT THE PATIENT'S VITALS WERE DECLINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535762 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-SPR-B0, STQ4-SPR-B0 SWO201029, SWO201029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention