BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11625493 · Received April 6, 2021

    Report

    Report Number
    3010676138-2021-00060
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 8, 2021
    Report Date
    March 8, 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 CLINICAL REPRESENTATIVE STATED THAT THE PATIENT HAS DIABETES AND THE WOUND HAS BEEN HEALING SLOWLY. THE IMPLANTING CLINICIAN EXAMINED THE PATIENT AND DECIDED TO REVISE THE STIMULATOR ON (B)(6) 2021. THE IMPLANTING CLINICIAN NOTED THAT THE PATIENT'S HYGIENE SEEMED TO BE POOR AND MIGHT HAVE CAUSED THE INCISION SITE INFECTION. BASED ON THIS INFORMATION, THE INFECTION WAS CONFIRMED/REPLICATED. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE INFECTION IS USER ERROR. DESIGN FMEA FOR STIMQ 06-01233 AND HRA FOR STIMQ 06-01232 WAS REVIEWED AND INFECTION IS A KNOWN ISSUE WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE AND NO CORRECTIVE ACTION IS REQUIRED. STIMWAVE'S GLOBAL INFECTION RATE: 0.67%

    Description of Event or Problem · 1

    ON(B)(6) 2021, THE CLINICAL REPRESENTATIVE BECAME AWARE THAT A RECENTLY IMPLANTED PATIENT HAD DEVELOPED AN INFECTION AT THE CALF SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514498 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0 SWO200320 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention