BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NEUROSTIMULATOR

    MDR report key: 19933680 · Received August 7, 2024

    Report

    Report Number
    3010878085-2024-00010
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 31, 2024
    Manufacturer
    VALENCIA TECHNOLOGIES
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    61 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 PATIENT REPORTED DISCHARGE COMING OUT AT THE BOTTOM OF INCISION. PATIENT STATED IT DOESN'T HURT JUST A LITTLE SWELLING. THE PATIENT WAS TREATED WITH BACTRIM AND RECOVERED AS OF (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534988 ECOIN PERIPHERAL NEUROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention