BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREEDOM PERIPHERAL NERVE STIMULATOR

    MDR report key: 16709949 · Received April 10, 2023

    Report

    Report Number
    3010676138-2023-00045
    Event Type
    Death
    Date Received
    April 10, 2023
    Date of Event
    March 8, 2023
    Report Date
    April 10, 2023
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020464
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE OTHER ADVERSE EVENTS ISSUES QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, THE INCIDENT TAKING PLACE BEFORE THE IMPLANT OF THE DEVICE, USING THE WAA DURING THE INCIDENT, IMPLANTING THE DEVICE AT AN OFF-LABEL LOCATION, MIGRATION, PUNCTURING BONE OR TISSUE INADVERTENTLY DURING THE PROCEDURE, REQUIRING MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY AND IMPLANTING THE STIMULATOR TOO CLOSE TO THE TARGETED NERVE HAVE BEEN RULED OUT AS POTENTIAL CAUSES. NO DEFICIENCIES OF CURONIX PRODUCTS HAVE BEEN REPORTED AND THE PROCEDURE WAS PERFORMED ACCORDING TO THE IFU. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE WAA FOR ENGINEERING INVESTIGATION. HOWEVER, THE DEVICE WAS NOT RETURNED. THEREFORE, THE WAA WAS NOT ANALYZED. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF DEATH IS RELATED TO NATURAL CAUSES. THE PROVIDED INFORMATION DOES NOT EVIDENCE THAT THE CURONIX DEVICE CONTRIBUTED TO THE ISSUE (NO FAULT FOUND). RATES REVIEWED AT THE MOST RECENT COMPLAINT TRENDING MEETING DO NOT INDICATE A SIGNIFICANT INCREASE IN OTHER ADVERSE EVENTS ISSUES. OTHER ADVERSE EVENTS ISSUES RATES REMAIN ACCEPTABLY LOW; THUS, CAPA IS NOT REQUIRED. OTHER ADVERSE EVENTS ISSUES RATES WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    THE PATIENT PASSED AWAY FROM NATURAL CAUSES AND NO DEFICIENCIES WERE REPORTED WITH THE CURONIX PRODUCTS. THE PATIENT PASSED AWAY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911537 FREEDOM PERIPHERAL NERVE STIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0, STQ4-SPR-B0 SWO210811A, SWO210809 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death WAA (PDBT-915-2K), SN: (B)(6).