BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIMED

    MDR report key: 23534339 · Received November 12, 2025

    Report

    Report Number
    3006630150-2025-10309
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 24, 2025
    Report Date
    March 11, 2026
    Manufacturer
    EPIMED INTERNATIONAL, INC
    Product Code
    LGW
    UDI-DI
    00818788020079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A MDR WAS SUBMITTED IN ERROR. THE REGULATORY REPORTING FOR THIS DEVICE IS THE RESPONSIBILITY OF THE MANUFACTURER (EPIMED INTERNATIONAL, INC) AND NOT BOSTON SCIENTIFIC. THEREFORE, PLEASE NOTE THAT THIS EVENT SHOULD NOT HAVE BEEN REPORTED ON A 3500A MDR FORM BY BOSTON SCIENTIFIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRIAL PROCEDURE, DURING THE PROCEDURE PHYSICIAN WAS UNABLE TO GAIN ACCESS TO THE EPIDURAL SPACE. PER PHYSICIAN, THIS ISSUE WAS NOT PROCEDURE OR DEVICE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRIAL PROCEDURE, DURING THE PROCEDURE PHYSICIAN WAS UNABLE TO GAIN ACCESS TO THE EPIDURAL SPACE. PER PHYSICIAN, THIS ISSUE WAS NOT PROCEDURE OR DEVICE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932397 EPIMED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW EPIMED INTERNATIONAL, INC 105-1314 121413787 00818788020079

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention