BEUDAMED
    FDA Adverse Event Death Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 13489118 · Received February 8, 2022

    Report

    Report Number
    3010676138-2022-00015
    Event Type
    Death
    Date Received
    February 8, 2022
    Date of Event
    January 10, 2022
    Report Date
    February 8, 2022
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020075
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE OTHER ADVERSE EVENTS ISSUES QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, LIMITED INFORMATION WAS PROVIDED. HOWEVER, NO DEFICIENCIES OF STIMWAVE PRODUCTS HAVE BEEN REPORTED. STIMWAVE QUALITY CONDUCTED MULTIPLE ATTEMPTS TO OBTAIN THE WAS FOR ENGINEERING TO INVESTIGATE THE DEVICES. HOWEVER, THE CLINICAL REPRESENTATIVE WAS UNABLE TO CONTACT THE PATIENT'S SPOUSE. THEREFORE THE WAS WERE NOT ANALYZED. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF DEATH IS RELATED TO A STROKE. THE PROVIDED INFORMATION DOES NOT EVIDENCE THAT THE STIMWAVE DEVICE CONTRIBUTED TO THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE OTHER ADVERSE EVENTS ISSUES QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, LIMITED INFORMATION WAS PROVIDED. HOWEVER, NO DEFICIENCIES OF STIMWAVE PRODUCTS HAVE BEEN REPORTED. STIMWAVE QUALITY CONDUCTED MULTIPLE ATTEMPTS TO OBTAIN THE WAAS FOR ENGINEERING TO INVESTIGATE THE DEVICES. HOWEVER, THE CLINICAL REPRESENTATIVE WAS UNABLE TO CONTACT THE PATIENT'S SPOUSE. THEREFORE THE WAAS WERE NOT ANALYZED. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF DEATH IS RELATED TO A STROKE. THE PROVIDED INFORMATION DOES NOT EVIDENCE THAT THE STIMWAVE DEVICE CONTRIBUTED TO THE ISSUE.

    Description of Event or Problem · 0

    THE PATIENT PASSED AWAY FROM A STROKE. NO ISSUES WERE REPORTED WITH THE STIMWAVE PRODUCTS. THE DATE OF THE PATIENT'S DEATH IS UNKNOWN.

    Description of Event or Problem · 0

    THE PATIENT PASSED AWAY FROM A STROKE. NO ISSUES WERE REPORTED WITH THE STIMWAVE PRODUCTS. THE DATE OF THE PATIENT'S DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895340 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. FR4A-RCV-A0 Q SWO180808 00818225020075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death STIMQ NEUSTIMULATOR, SN: (B)(4), LN: SWO190129| WAA (PDBT-915-2K), SN: (B)(4)| WAA (PDBT-915-2K), SN: (B)(4)| WAA (PDBT-915-2K), SN: (B)(4)