BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11888677 · Received May 26, 2021

    Report

    Report Number
    3010676138-2021-00101
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 26, 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 CLINICAL REPRESENTATIVE NOTED THAT HE WAS UNSURE IF CULTURES WERE TAKEN AT THE TIME OF THE EXPLANT PROCEDURE. ON (B)(6) 2021, THE CLINICAL REPRESENTATIVE WAS INFORMED BY THE PATIENT OF A RECENT VISIT TO THE EMERGENCY ROOM FOR INCREASED PAIN FOLLOWING THE EXPLANT PROCEDURE AND THE PATIENT WAS ADMITTED FOR SURGERY TO CLEAN OUT THE INFECTION. THE STIMWAVE REPRESENTATIVE ASSIGNED TO THIS CASE HAS NOT BEEN ABLE TO OBTAIN ANY FURTHER UPDATES FROM THE PATIENT. THE SURGICAL ISSUE QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, IMPLANTING A NON-STERILE DEVICE, THE PATIENT ENGAGING IN STRENUOUS OR PHYSICAL ACTIVITY FOLLOWING THE PROCEDURE, IMPLANTING AN EXPIRED PRODUCT, NOT PREPPING THE SKIN, USING INAPPROPRIATE TOOLS, PATIENT PICKING AT THE WOUND, NOT IRRIGATING THE INCISION SITE, AND MULTIPLE TUNNELING ATTEMPTS HAVE BEEN RULED OUT AS POTENTIAL CAUSES. THE IMPLANTING CLINICIAN STATES THE REASON FOR THE INFECTION IS UNKNOWN. 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 FOR THE TREATMENT OF PAIN. THE CAUSE OF THE INFECTION IS UNKNOWN/NO FAULT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE STIMULATOR WAS SUCCESSFULLY EXPLANTED, AND THE IMPLANTING CLINICIAN NOTED DURING THE EXPLANT THAT THE INFECTION DID NOT APPEAR TO BE SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787309 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. SWO201025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention