BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITIVE ARTHRITIS KNEE

    MDR report key: 7937855 · Received October 5, 2018

    Report

    Report Number
    3010078417-2018-00009
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    August 21, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ACTEGY LTD
    Product Code
    NGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FEMALE CUSTOMER ((B)(6)) USED THE DEVICE ON TUESDAY (B)(6) 2018 IN THE MORNING AND BEGAN TO FEEL CHEST PAINS ON TUESDAY EVENING. SHE WENT TO THE DOCTORS ON WEDNESDAY MORNING AND THE DOCTOR CALLED AN AMBULANCE FOR HER TO GO TO (B)(6) HOSPITAL IN (B)(6). THEY CONFIRMED THAT SHE HAD A HEART ATTACK AND DID AN ANGIOGRAM. THE HOSPITAL CONFIRMED THAT (B)(6) HAD A HEART ATTACK. SUBSEQUENTLY AFTER LEAVING HOSPITAL THE CUSTOMER SUFFERED ANOTHER HEART ATTACK ON (B)(6) 2018. CUSTOMER QUESTIONNAIRE COMPLETED OVER THE TELEPHONE WITH THE HELP OF HER DAUGHTER ((B)(6)) ON (B)(6) 2018. DEVICE RETURNED TO ACTEGY LTD AND TESTED ON 1 OCTOBER 2018 AND TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779072 REVITIVE ARTHRITIS KNEE CIRCULATION BOOSTER NGX ACTEGY LTD REVITIVE ARTHRITIS KNEE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L