BEUDAMED
    FDA Adverse Event Death Summary report: N

    STIMQ PERIPHERAL NERVE STIMULATOR

    MDR report key: 9365256 · Received November 22, 2019

    Report

    Report Number
    3010676138-2019-00053
    Event Type
    Death
    Date Received
    November 22, 2019
    Report Date
    November 22, 2019
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IMMEDIATELY FOLLOWING NOTIFICATION, STIMWAVE QUALITY AND THE TERRITORY MANAGER REVIEWED EVENTS PRECEDING THE ISSUE. THE PATIENT HAD A PERMANENT PROCEDURE PERFORMED ON (B)(6) 2019, IN WHICH ONE (1) STIMQ RECEIVER STIMULATOR (STQ4-RCV-A0) WAS IMPLANTED AT THE GENICULAR NERVE TO TREAT THE PATIENT'S LEG PAIN CAUSED BY THE PATIENT'S CEREBROVASCULAR DISEASE. THE TERRITORY MANAGER CONFIRMED THE IMPLANT PROCEDURE WAS PERFORMED IN A STERILE ENVIRONMENT STERILE FIELD HANDLING PROTOCOLS WERE USED, THE PROCEDURE WAS COMPLETED IN ACCORDANCE WITH THE PRODUCT INSTRUCTIONS FOR USE, AND THE STERILE BARRIERS OF ALL PRODUCT USED WERE INTACT PRIOR TO IMPLANT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION, AND THE TERRITORY MANAGER MAINTAINED CONTACT WITH THE PATIENT FOLLOWING IMPLANT. ON AN UNKNOWN DATE THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ILLNESS CAUSED BY THE PATIENT'S CEREBROVASCULAR DISEASE. IT IS UNKNOWN AT THIS TIME THE TYPE OF ILLNESS OR SYMPTOMS THE PATIENT WAS EXPERIENCING. ON (B)(6) 2019, STIMWAVE WAS NOTIFIED THAT THE PATIENT HAD PASSED AWAY DUE TO THEIR UNDERLYING CEREBROVASCULAR DISEASE. THE ATTENDING PHYSICIAN AT THE HOSPITAL REPORTED THAT THE CAUSE OF DEATH WAS DUE TO THE PATIENT'S DISEASE. THE DEVICE WAS NOT THE SOURCE OF THE ISSUE. STIMWAVE CONFIRMED THAT THE DEVICE DID NOT FAIL TO MEET PERFORMANCE OR SAFETY SPECIFICATION. THE DEVICE CONTINUED WORKING AS EXPECTED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ATTRIBUTED TO THE PATIENT'S CEREBROVASCULAR DISEASE. THE ROOT CAUSE OF THE COMPLAINT IS NOT ATTRIBUTED TO DEVICE FAILURE, THE INABILITY OF THE DEVICE TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS, OR NONCONFORMANCE TO PHYSICAL OR FUNCTIONAL DEVICE SPECIFICATIONS. THE STIMWAVE PRODUCT WAS NOT THE SOURCE OF THE ISSUE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ATTRIBUTED TO THE PATIENT'S CEREBROVASCULAR DISEASE. CORRECTIVE ACTION IS NOT REQUIRED TO REMEDY THE ROOT CAUSE OF THE COMPLAINT. THE DEVICE DID NOT FAIL TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS. STIMWAVE CONFIRMED THE ISSUE IS NOT RELATED TO THE DEVICE. STIMWAVE WAS IN CONSTANT CONTACT WITH THE TERRITORY MANAGER STARTING OCTOBER 25, 2018, REGARDING THE COMPLAINT AND THE ROOT CAUSE INVESTIGATION. STIMWAVE CONFIRMED THAT THE PRODUCT DID NOT FAIL TO PERFORM ITS ESSENTIAL FUNCTIONS. THE CAUSE OF THE REPORTED EVENT WAS DUE TO THE PATIENT'S PREVIOUS DISEASE. STIMWAVE HAS INFORMED ALL PARTIES THAT THE STIMQ PRODUCT DID NOT MALFUNCTION AND WAS NOT THE SOURCE OF THE ISSUE. IN COMPLIANCE WITH MEDICAL DEVICE REPORTING REQUIREMENTS AND RESPONSIBILITIES, STIMWAVE QUALITY AND ITS CHIEF MEDICAL OFFICER HAVE DETERMINED THAT THIS ISSUE IS REPORTABLE AS THE EVENT LED TO A DEATH. THIS EVENT WAS REPORTED TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) ON NOVEMBER 22, 2019.

    Description of Event or Problem · 1

    STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM A PATIENT DEATH, UNRELATED TO DEVICE, REPORTED TO STIMWAVE ON (B)(6) 2019, BY TERRITORY MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157736 STIMQ PERIPHERAL NERVE STIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0 SWO190129 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Death