BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11758577 · Received May 1, 2021

    Report

    Report Number
    3010676138-2021-00082
    Event Type
    Injury
    Date Received
    May 1, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 1, 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

    ON (B)(6) 2021, THE STIMULATOR WAS SUCCESSFULLY EXPLANTED, AND NO FURTHER ISSUES WERE REPORTED. THE CLINICAL REPRESENTATIVE NOTED THAT THE PATIENT WAS DOING FINE AFTER THE EXPLANT. THE CLINICAL REPRESENTATIVE STATED THE PHYSICIAN IDENTIFIED THE PROBLEM WHEN IT WAS NOTICED THE WOUND WAS NOT HEALING. THE IMPLANTING CLINICIAN HAD TAPED A DEMO LEAD TO THE PATIENT TO SEE HOW SHE REACTED TO TEST FOR METAL ALLERGIES, AND THE TRIAL WENT WELL WITH NO REACTIONS. HOWEVER, ONCE THE IMPLANT PROCEDURE WAS PERFORMED, THE PATIENT DEVELOPED ISSUES WITH WOUND HEALING. IT WAS HYPOTHESIZED THAT THE PATIENT WAS HAVING AN ALLERGIC REACTION TO THE METAL IN THE ELECTRODE ARRAY. BASED ON THIS INFORMATION, THE WOUND NOT HEALING WAS CONFIRMED/REPLICATED. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED FOR THE TREATMENT OF PAIN. THE CAUSE OF THE WOUND NOT HEALING IS THE PATIENT POTENTIALLY EXPERIENCING A REACTION TO THE METAL IN THE ELECTRODE ARRAY. HOWEVER, THE STIMULATOR ELECTRODES ARE COMPRISED OF HYPOALLERGENIC METALS. PER PREVIOUS INVESTIGATIONS CONDUCTED FOR THE SAME REPORTED ISSUE, THE FOLLOWING ARE POTENTIAL CAUSES OF THE EVENT: PATIENT NOT FOLLOWING POST-OP INSTRUCTIONS. NOT FOLLOWING IFU DURING THE IMPLANT PROCEDURE. STITCHING ON THE WOUND NOT PERFORMED CORRECTLY. NOT PRESCRIBING ANTIBIOTICS PRIOR TO THE IMPLANT PROCEDURE. DRESSING NOT DONE PROPERLY. PATIENT HAS PRE-EXISTING CONDITIONS. MDRS ARE TRACKED AND TRENDED AS PART OF MANAGEMENT REVIEW. IN ADDITION, WOUND NOT HEALING IS LISTED AS A KNOWN ADVERSE EVENT IN THE INSTRUCTIONS FOR USE (05-20200).

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CLINICAL REPRESENTATIVE BECAME AWARE A RECENTLY IMPLANTED PATIENT WAS EXPERIENCING AN ALLERGIC REACTION TO THE METAL IN THE ELECTRODE ARRAY, AND THE IMPLANTING CLINICIAN WANTED TO PERFORM AN EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654930 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0 SWO201025 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention