BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITIVE IX

    MDR report key: 7552167 · Received May 30, 2018

    Report

    Report Number
    3010078417-2018-00002
    Event Type
    Injury
    Date Received
    May 30, 2018
    Date of Event
    October 20, 2016
    Report Date
    May 30, 2018
    Manufacturer
    ACTEGY LTD
    Product Code
    NUH
    PMA / PMN Number
    K143207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY FOLLOWING THE DEATH OF THE CUSTOMER NO FURTHER INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    PLEASE NOTE: FOLLOWING AN FDA INSPECTION AT ACTEGY LTD BETWEEN (B)(6) 2018 BY MR (B)(6) IT WAS IDENTIFIED THIS INCIDENT SHOULD HAVE BEEN REPORTED TO FDA. THEREFORE, THE FOLLOWING INCIDENT IS BEING REPORTED RETROSPECTIVELY: THE PATIENT NOTIFIED ACTEGY ON THE (B)(6) 2016 THAT HE HAD RECEIVED AN ELECTRIC SHOCK FROM THE DEVICE. FOLLOWING THE FDA FINDING AN ATTEMPT WAS MADE TO CONTACT THE CUSTOMER BUT WE WERE TOLD THAT SADLY HE HAD DIED (BUT NOT AS A RESULT OF THE REVITIVE IX CIRCULATION BOOSTER). ACTEGY CUSTOMERS ARE TYPICALLY AGED 70+ AND THIS OCCASIONALLY HAPPENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396504 REVITIVE IX CIRCULATION BOOSTER NUH ACTEGY LTD IX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention