BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOIN PERIPHERAL NUEROSTIMULATOR

    MDR report key: 17603891 · Received August 23, 2023

    Report

    Report Number
    3010878085-2023-00007
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 31, 2023
    Report Date
    September 18, 2023
    Manufacturer
    VALENCIA TECHNOLOGIES
    Product Code
    QPT
    UDI-DI
    00860007896903
    PMA / PMN Number
    P200036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 25, 2023, VTC RECEIVED A REPORT THAT THE INFECTION HAD REGRESSED AND THE PATIENT WAS EXPLANTED. VTC RECEIVED THE EXPLANT ON (B)(6) 2023. THE FAILURE ANALYSIS TEAM PERFORMED VISUAL INSPECTION AND RAN FINAL DEVICE ELECTRICAL TEST ON THE DEVICE AND FOUND NO RELATED ISSUES WITH THE DEVICE. THE INVESTIGATION FOUND NO ISSUES OR USE ERRORS TO THE REPORTED ISSUE. THE CAUSE OF THE INFECTION IS NOT DETERMINED.

    Description of Event or Problem · 0

    73 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2023. AT THEIR 2 WEEK HEALING CHECK, THE IMPLANTING PHYSICIAN NOTED A POTENTIAL INFECTION AND PATIENT WAS PRECRIBED A ROUND OF ANTIBIOTICS (I.E. CLYNDAMIACIN). ON (B)(6) 2023, THE PATIENT WAS SEEN FOR THEIR ACTIVATION APPOINTMENT. THE PATIENT PRESENTED WITH CONTINUED SIGNS OF INFECTION (I.E. AREA WAS SLIGHTLY RED, AND SKIN AROUND INCISION WAS HARD). ON (B)(6) 2023, PATIENT WAS CLEARED FOR ACTIVATION BY THE PHYSICIAN. ON (B)(6) 2023, AN UPDATE WAS RECEIVED THAT THE PATIENT IS HEALED AND THE INCISION CLEARED BY THE PHYSICIAN.

    Description of Event or Problem · 0

    73 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2023. AT THEIR 2 WEEK HEALING CHECK, THE IMPLANTING PHYSICIAN NOTED A POTENTIAL INFECTION AND PATIENT WAS PRESCRIBED A ROUND OF ANTIBIOTICS (I.E. CLINDAMYCIN). ON (B)(6) 2023, THE PATIENT WAS SEEN FOR THEIR ACTIVATION APPOINTMENT. THE PATIENT PRESENTED WITH CONTINUED SIGNS OF INFECTION (I.E. AREA WAS SLIGHTLY RED, AND SKIN AROUND INCISION WAS HARD). ON (B)(6) 2023, PATIENT WAS CLEARED FOR ACTIVATION BY THE PHYSICIAN. ON 08/16/2023, AN UPDATE WAS RECEIVED THAT THE PATIENT IS HEALED AND THE INCISION CLEARED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483285 ECOIN PERIPHERAL NUEROSTIMULATOR ECOIN QPT VALENCIA TECHNOLOGIES 00860007896903

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention