BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 12019253 · Received June 17, 2021

    Report

    Report Number
    3010676138-2021-00127
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 17, 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, PATIENT PICKING ON THE WOUND, PATIENT ENGAGING IN STRENUOUS ACTIVITIES, USING INAPPROPRIATE TOOLS, AND MULTIPLE TUNNELING ATTEMPTS HAVE BEEN RULED OUT AS POTENTIAL CAUSES. HOWEVER, THE QUESTIONNAIRE SHOWS THE PATIENT HAD PRE-EXISTING MEDICAL CONDITIONS. THE IMPLANTING CLINICIAN STATED THE EROSION MIGHT HAVE BEEN LINKED TO THE PATIENT BEING A SMOKER, MAKING THE INCISION WOUND TAKE LONGER TO HEAL. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF EROSION IS 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 DISCLOSED THE LEADS HAD ERODED. THE IMPLANTING CLINICIAN PERFORMED A REVISION ON (B)(6) 2021 AND TWO NEW LEADS WERE IMPLANTED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911141 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0, STQ4-SPR-B0 SWO200929, SWO201029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention