BEUDAMED
    FDA Adverse Event Death Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 12222730 · Received July 24, 2021

    Report

    Report Number
    3010676138-2021-00157
    Event Type
    Death
    Date Received
    July 24, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 24, 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

    CLINICAL REPRESENTATIVE REPORTING THE DEATH OF A PATIENT WHO WENT INTO SEPTIC SHOCK DUE TO A PRE-EXISTING CONDITION AND PASSED AWAY. THE DEATH IS NOT RELATED TO THE STIMULATOR AND THE PATIENT WAS RECEIVING ADEQUATE THERAPY. THE SURGICAL ISSUE (UNRELATED TO STIMULATOR) QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, THE STIMULATOR NOT IMPLANTED SUCCESSFULLY, BONE PUNCTURING DURING THE PROCEDURE, MEDICAL INTERVENTION REQUIRED TO PREVENT SEVERE INJURY OR DEATH, AND FRACTURE OR TISSUE DAMAGE HAVE BEEN RULED OUT AS POTENTIAL CAUSES. THE CLINICAL REPRESENTATIVE DISCLOSED THE PATIENT HAD BEEN STRUGGLING WITH PRE-EXISTING CONDITIONS (LUPUS), WHICH CAUSED TO THE EVENT. 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. THE CAUSE OF THE DEATH IS NO PROBLEM/FAULT FOUND RELATED TO PRODUCT OR PROCEDURE.

    Description of Event or Problem · 1

    PATIENT PASSED AWAY AFTER STRUGGLING WITH LUPUS FOR MANY YEARS. THE PATIENT WENT INTO SEPTIC SHOCK AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119658 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0 SWO190414 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Death