BEUDAMED
    FDA Adverse Event Death Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 12804838 · Received November 12, 2021

    Report

    Report Number
    3010676138-2021-00227
    Event Type
    Death
    Date Received
    November 12, 2021
    Date of Event
    September 25, 2021
    Report Date
    November 11, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020150
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BOTH WEARABLE ANTENNA ASSEMBLY UNITS ASSOCIATED WITH THIS MDR WERE NOT USED WHEN THE OCCURRENCE TOOK PLACE. THE PROCEDURE WAS PERFORMED ACCORDING TO THE IFU. IN ADDITION, THE STIMULATORS WITH THE SYSTEM: WERE NOT IMPLANTED AT AN OFF-LABEL LOCATION. WERE NOT IMPLANTED TOO CLOSE TO THE TARGETED NERVE. MIGRATION DID NOT OCCUR. BONE OR TISSUE WAS NOT INADVERTENTLY PUNCTURED DURING THE PROCEDURE. THE WAAS ASSOCIATED WITH THIS COMPLAINT ( (B)(4) ) WERE RETURNED FOR INVESTIGATION. THE INVESTIGATIONS CONCLUDED THAT THE UNITS PERFORMED AS EXPECTED AND NO ISSUES WERE FOUND. A STIMWAVE REPRESENTATIVE CONDUCTED A REVIEW OF STERILIZATION AND PACKAGING RECORDS FOR THE RESPECTIVE PRODUCT LOT; 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 STIMULATOR IS USED TO TREAT PAIN. BASED ON THIS OBJECTIVE EVIDENCE, THE CAUSE OF THE DEATH IS UNKNOWN AND UNRELATED TO THE STIMWAVE PRODUCTS (NO PROBLEM/FAULT FOUND).

    Description of Event or Problem · 0

    THE PATIENT DIED OF NATURAL CAUSES ON (B)(6) 2021. THERE WERE NO ISSUES REPORTED WITH THE STIMWAVE PRODUCTS. THE PATIENT'S WIFE WOULD LIKE TO RETURN BOTH WEARABLE ANTENNA ASSEMBLY UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703356 STIMQ NEUROSTIMULATOR WEARABLE ANTENNA ASSEMBLY GZF STIMWAVE TECHNOLOGIES INC. PDBT-915-2K 00443-LT 00818225020150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death STIMQ NEUROSTIMULATOR, SN: (B)(4), LN:SWO190904| STIMQ NEUROSTIMULATOR, SN: (B)(4), LN:SWO191202| WAA (PDBT-915-2K), SN: 6827190B2C1A