BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11634876 · Received April 8, 2021

    Report

    Report Number
    3010676138-2021-00063
    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
    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 IMPLANTING CLINICIAN EXPLAINED TO THE CLINICAL REPRESENTATIVE THE LEADS WERE NOT VISIBLE. HOWEVER, A VERY SMALL PORTION OF SOMETHING BLUE WAS VISIBLE, WHICH THE IMPLANTING CLINICIAN BELIEVES IS THE SUTURE ERODING, NOT THE STIMULATOR. THE CLINICAL REPRESENTATIVE CONFIRMED THAT THE IMPLANT PROCEDURES WERE COMPLETED IN ACCORDANCE WITH THE PRODUCT INSTRUCTIONS FOR USE. THE PATIENT REPORTED RECEIVING THERAPY. THE IMPLANTING CLINICIAN INSPECTED THE SITE AND DECIDED NOT TO REVISE THE SUTURE. BASED ON THIS INFORMATION, THE DEVICE EROSION WAS NOT 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 SUTURE EROSION IS UNKNOWN/NO PROBLEM FOUND; THE DEVICE DID NOT ERODE. DESIGN FMEA 06-0537 AND HRA 06-0524 WAS REVIEWED AND DEVICE EROSION IS A KNOWN ISSUE WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE THEREFORE, NO CAPA IS REQUIRED. STIMWAVE'S GLOBAL DEVICE EROSION RATE: 0.32% AND THE IMPACT IS IMPORTANT AND THE FREQUENCY IS OCCASIONALLY.

    Description of Event or Problem · 1

    ON (B)(6) THE CLINICAL REPRESENTATIVE WAS CONTACTED BY THE IMPLANTING CLINICIAN TO DISCLOSE THAT A RECENTLY IMPLANTED PATIENT WITH ONE STIM-Q STIMULATOR AT THE LEFT KNEE HAD AN EROSION AT THE SURGICAL POCKET SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532046 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0 SWO200608 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Other