BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11301498 · Received February 9, 2021

    Report

    Report Number
    3010676138-2021-00004
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 5, 2021
    Report Date
    February 9, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT-REPORTED ATTENDING A FOLLOW-UP APPOINTMENT WITH A PRIMARY CARE PHYSICIAN, WHO ADVISED THE PATIENT TO FOLLOW-UP WITH THE IMPLANTING CLINICIAN BECAUSE THE WOUND SEEMED TO BE INFECTED AND ONE OF THE LEADS APPEARED TO BE ERODING. THE PATIENT REACHED OUT TO THE CLINICAL REPRESENTATIVE IMMEDIATELY. THE CLINICAL REPRESENTATIVE RECOMMENDED THE PATIENT CALL THE IMPLANTING CLINICIAN'S OFFICE AND SCHEDULE A FOLLOW-UP. ON (B)(6) 2020, THE PATIENT WAS SEEN BY ONE OF THE ASSOCIATES OF THE IMPLANTING CLINICIAN, WHO DETERMINED THAT THE TAIL OF THE LEAD WAS PROTRUDING OUT OF THE PATIENT'S INCISION AND RECOMMENDED THE LEADS BE REMOVED AND RE-IMPLANTED. THE PATIENT WAS INSTRUCTED TO FOLLOW-UP WITH THE IMPLANTING CLINICIAN ON (B)(6) 2020, TO DISCUSS FURTHER OPTIONS. ON (B)(6) 2020, THE IMPLANTING CLINICIAN TOLD THE PATIENT THAT THE PLAN IS TO EXPLANT AND IMPLANT NEW LEADS IMMEDIATELY AFTER BWC GRANTS THE APPROVAL. ON (B)(6) 2021, THE CLINICAL REPRESENTATIVE WAS MADE AWARE BY THE PATIENT THAT DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2020, THAT THE INFECTION WAS FOUND TO BE GETTING WORSE, AND THE IMPLANTING CLINICIAN EXPLANTED BOTH LEADS AND PRESCRIBED ANTIBIOTICS (DOSAGE, NAME, FREQUENCY UNKNOWN) TO TREAT THE INFECTION. THE IMPLANTING CLINICIAN PLANS TO IMPLANT NEW STIMULATORS ONCE THE INFECTION HAS CLEARED. THE PROCEDURE WAS REPORTED TO HAVE BEEN PERFORMED PER THE PRODUCT IFU. 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 CAUSE OF THE INFECTION IS NO PROBLEM FOUND.

    Description of Event or Problem · 1

    COMPLAINT (B)(4) WAS RECEIVED ON (B)(6) 2020. THE CLINICAL REPRESENTATIVE WAS MADE AWARE THAT A RECENTLY IMPLANTED PATIENT WAS SUSPECT OF POTENTIAL INFECTION AND EROSION AT THE WOUND SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196652 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-SPR-B0, STQ4-RCV-A0 SWO200305, SWO200320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention