BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITIVE IX

    MDR report key: 7549033 · Received May 29, 2018

    Report

    Report Number
    3010078417-2018-00001
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    September 12, 2016
    Report Date
    May 29, 2018
    Manufacturer
    ACTEGY LTD
    Product Code
    NUH
    PMA / PMN Number
    K143207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER (MR (B)(6)) CUSTOMER CARE MANAGED TO CONTACT THE MR (B)(6) ON APRIL 13, 2018 AND CONFIRMED THE FOLLOWING: A) HE HAD NEVER VISITED HIS DOCTOR OR HOSPITAL CONCERNING THIS REPORTED INCIDENT. B) THAT HE WAS SUFFERING FROM POOR CIRCULATION AND HAD A SELF-EXPANDING STENT SYSTEM PUT IN AND WAS NOT OVERWEIGHT. C) HE HAD SPOKEN TO CUSTOMER CARE ON HOW BEST USE THE DEVICE, USE LOTION, KEEP HYDRATED AND NOT TURN THE DEVICE UP TOO HIGH. D) ADMITTED THAT INITIALLY HE HAD NOT USED THE DEVICE CORRECTLY TURNING THE INTENSITY UP TOO HIGH. FOLLOWING HIS CONVERSATION WITH CUSTOMER CARE HE WAS NOW USING THE DEVICE CORRECTLY AS SPECIFIED IN THE IFU TO AVOID A SIMILAR RECURRENCE. E) HIS DOCTOR IS HAPPY THAT HIS CIRCULATION HAS IMPROVED AND THAT HE CONTINUES TO USE THE DEVICE.

    Description of Event or Problem · 1

    PLEASE NOTE: FOLLOWING AN FDA INSPECTION AT ACTEGY LTD BETWEEN MARCH 5-8, 2018 BY MR (B)(6) IT WAS IDENTIFIED THIS INCIDENT SHOULD HAVE BEEN REPORTED TO FDA. THEREFORE, THE FOLLOWING INCIDENT IS BEING REPORTED RETROSPECTIVELY: CUSTOMER REPORTED "ELECTRIC SHOCK IN HIS LEFT FOOT THAT WAS PAINFUL AND IT ALSO HAPPENED WITH THE REPLACEMENT. RIGHT AT THE END OF HIS BIG TOE AND AFTER ABOUT TEN MINUTES OF USE WHEN HE WAS ON THE PHONE WITH CUSTOMER CARE. WHEN HE FIRST USED THE REPLACEMENT MACHINE HE SUFFERED THE SHOCK SENSATION IMMEDIATELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391306 REVITIVE IX CIRCULATION BOOSTER NUH ACTEGY LTD IX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR