BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NUEROSTIMULATOR

    MDR report key: 17487994 · Received August 9, 2023

    Report

    Report Number
    3010878085-2023-00005
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 9, 2023
    Manufacturer
    VALENCIA TECHNOLOGIES
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    68 YEAR OLD FEMALE WAS IMPLANTED ON (B)(6) 2023. THEY WERE SEEN AT THEIR 4 WEEK ACTIVATION APPOINTMENT ON (B)(6) 2023. THERE WERE NO ISSES NOTED RELATED TO HEALING OF THE INCISION AND THEY WERE CLEARED BY THE IMPLANTING PHYSICIAN FOR ACTIVATION. ON (B)(6) 2023, THE PATIENT CALLED INTO THE PHYSICIAN'S OFFICES TO REPORT OBSERVED SIGNS OF AN INFECTION (I.E. REDNESS AND PUSS) AND INCLUDES A PICTURE OF THE SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICIS (AUGMENTIN). THE IMPLANTING PHYSICIAN NOTIFIED VTC SALES PERSONNEL AT THIS TIME. UPDATES FOR THE PATIENT WERE GIVEN TO VTC ON (B)(6) 2023 THAT THE INCISION SITE AND INFECTION WERE "LOOKING MUCH BETTER". UPDATE ON (B)(6) 2023, IMPLANTING PHYSICIAN COMMUNICATED THAT THE INCISION HAS "HEALED WELL" AND "HAS NO REDNESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689215 ECOIN PERIPHERAL NUEROSTIMULATOR ECOIN QPT VALENCIA TECHNOLOGIES 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention