BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 12030077 · Received June 19, 2021

    Report

    Report Number
    3010676138-2021-00129
    Event Type
    Injury
    Date Received
    June 19, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 19, 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 SURGICAL ISSUE QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, IMPLANTING A NON-STERILE DEVICE, NOT USING ANTIBIOTICS USING INAPPROPRIATE TOOLS, PATIENT PICKING THE WOUND, AND MULTIPLE TUNNELING ATTEMPTS HAVE BEEN RULED OUT AS POTENTIAL CAUSES. THE IMPLANTING CLINICIAN STATED THAT THE CAUSE OF THE INFECTION WAS UNKNOWN. HOWEVER, THE QUESTIONNAIRE SHOWS THE CLINICAL REPRESENTATIVE IS UNSURE IF THE IMPLANTING CLINICIAN IRRIGATED THE SITE OR PREPARED THE SURFACE OF THE SKIN AND THE PATIENT HAS A PRE-EXITING MEDICAL CONDITION. 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 INFECTION MAY BE DUE TO NOT IRRIGATING THE IMPLANT SITE AND/OR DUE TO THE PATIENT BEING A POTENTIAL POOR CANDIDATE DUE TO HEALTH, WEIGHT, AGE OR MENTAL CAPACITY AND CLINICIAN KNOWINGLY IMPLANTING THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT IS REPORTING INFECTION AND IS BEING TREATED WITH ANTIBIOTICS, WITH NO REVISION/EXPLANT ANTICIPATED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926835 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention