BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11986403 · Received June 11, 2021

    Report

    Report Number
    3010676138-2021-00123
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 3, 2021
    Report Date
    June 11, 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

    THE SURGICAL ISSUE QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, IMPLANTING A NON-STERILE DEVICE, PATIENT ENGAGING IN STRENUOUS ACTIVITIES, IMPLANTING AN EXPIRED DEVICE, USING INAPPROPRIATE TOOLS, AND MULTIPLE TUNNELING ATTEMPTS HAVE BEEN RULED OUT AS POTENTIAL CAUSES. THE IMPLANTING CLINICIAN STATED THAT THE CAUSE OF THE MIGRATION IS RELATED TO THE ANCHOR SUTURES WERE NOT DEEP ENOUGH AND LIKELY IN ADIPOSE TISSUE ALLOWING THE MIGRATION TO TAKE PLACE. THE STIMULATOR IS USED FOR THE TREATMENT OF PAIN. THE CAUSE OF THE MIGRATION IS IMPROPER SURGICAL TECHNIQUE AND CLINICIAN USER ERROR DUE TO ANCHORING AT INADEQUATE DEPTH.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HAVING DISCOMFORT IN THE RIGHT KNEE CAP AREA. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2021 DUE TO MIGRATION AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877471 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0 SWO201025 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention