BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NUEROSTIMULATOR

    MDR report key: 17279119 · Received July 7, 2023

    Report

    Report Number
    3010878085-2023-00004
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 7, 2023
    Manufacturer
    VALENCIA TECHNOLOGIES
    Product Code
    QPT
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OVERWEIGHT, FEMALE PATIENT WAS RE-IMPLANTED ON (B)(6) 2023 PER PATIENT'S REQUEST AS PART OF THE PIVOTAL CLINICAL STUDY. THEY WERE SEEN FOR A WOUND HEALING CHECK ON (B)(6) 2023. THERE WERE NO RELATED ISSUES NOTED AT THE HEALING CHECK. ON (B)(6) 2023, PATIENT WAS ON VACATION ABOARD A CRUISE SHIP AND NOTICED REDNESS AT THE INCISION SITE. THE PATIENT WAS SEEN AT A WALK IN CLINIC AND REPORTED TRAUMA AT THE SITE ON (B)(6) 2023. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC. PATIENT MESSAGED THE IMPLANTING PHYSICIAN'S CLINIC, WHOM AGREED WITH THE TREATMENT. ON (B)(6) 2023, PATIENT COMMUNICATED THAT THE INCISION SITE WAS IMPROVING. ON (B)(6) 2023, THE PATIENT WAS SEEN BY THE IMPLANTING PHYSICIAN WHO NOTED THE INFECTION HAD CLEARED. PATIENT WAS ACTIVATED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014443 ECOIN PERIPHERAL NUEROSTIMULATOR ECOIN UUI QPT VALENCIA TECHNOLOGIES 1011-2447

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention