BEUDAMED
    FDA Adverse Event Death Summary report: N

    STIMQ PERIPHERAL NERVE STIMULATOR

    MDR report key: 9365397 · Received November 22, 2019

    Report

    Report Number
    3010676138-2019-00054
    Event Type
    Death
    Date Received
    November 22, 2019
    Report Date
    November 22, 2019
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020693
    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) AND ONE (1) SPARE LEAD (STQ4-SPR-B0) WERE IMPLANTED AT THE MEDIAL CLUNEAL. THE TERRITORY MANAGER CONFIRMED THAT 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 (B)(6) 2019, THE TERRITORY MANAGER WAS NOTIFIED BY THE PATIENT'S FAMILY THAT THE PATIENT HAD PASSED AWAY. THE PATIENT HAD MULTIPLE COMORBIDITIES AND WAS OF OLD AGE. THE PATIENT'S PHYSICIAN ATTRIBUTED THE DEATH TO NATURAL CAUSES. THE PATIENT'S FAMILY REPORTED THE DEVICE WAS WORKING AS EXPECTED. THE DEVICE WAS PROVIDING THERAPY UNTIL THE PATIENT'S DEATH. THE ROOT CAUSE OF THE ISSUE CANNOT BE TRACED TO THE DEVICE. THE ROOT CAUSE IS ATTRIBUTED TO PATIENT COMORBIDITIES. 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 DEVICE WAS WORKING AS EXPECTED AND WAS PROVIDING THERAPY TO THE PATIENT. THE ROOT CAUSE OF THE ISSUE IS ATTRIBUTED TO PATIENT COMORBIDITIES. 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 ROOT CAUSE OF THE ISSUE IS NOT ATTRIBUTED TO THE DEVICE. STIMWAVE WAS IN CONSTANT CONTACT WITH THE TERRITORY MANAGER FROM (B)(6) 2019, ONWARD REGARDING THE COMPLAINT AND THE ROOT CAUSE INVESTIGATION. STIMWAVE CONFIRMED THAT THE PRODUCT DID NOT FAIL TO MEET PERFORMANCE AND SAFETY SPECIFICATIONS. THE SOURCE OF THE ISSUE IS ATTRIBUTED TO PATIENT COMORBIDITIES. STIMWAVE HAS INFORMED ALL PARTIES THAT THE PRODUCT WAS NOT THE SOURCE ISSUE. IN COMPLIANCE WITH MEDICAL DEVICE REPORTING REQUIREMENTS AND RESPONSIBILITIES, STIMWAVE QUALITY AND ITS CHIEF MEDICAL OFFICER HAVE DETERMINED THAT THIS ISSUE IS CONSIDERED REPORTABLE AS THE EVENT RESULTED IN A DEATH. THIS EVENT HAS BEEN 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 PATIENT DEATH, UNRELATED TO THE DEVICE, REPORTED TO STIMWAVE ON NOVEMBER 1, 2019, BY TERRITORY MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155502 STIMQ PERIPHERAL NERVE STIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. FR8A-RCV-A0, FR8A-SPR-B0 SWO190202, SWO190414 00818225020693

    Patients

    Seq Age Sex Outcome Treatment
    1 Death