BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 20045874 · Received August 23, 2024

    Report

    Report Number
    3006630150-2024-05531
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779919
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(6), BATCH: 7072812.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE PADDLE LEADS OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. IT WAS STATED THAT THE PADDLE LEADS WERE TOO FAR FROM THE SPINAL CORD WHICH WAS THE CAUSE OF THE INADEQUATE STIMULATION. IT IS UNKNOWN IF THIS WAS DUE TO THE ORIGINAL PLACEMENT OF THE DEVICES OR IF IT WAS DUE TO THE PROGRESSION OF THE PATIENTS' PAIN. REPROGRAMMING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE PADDLE LEADS WERE EXPLANTED AND REPLACED WITH NEW DEVICES, AND THE PATIENT IS DOING WELL POST OPERATIVELY. THE PADDLE LEADS WERE NOT RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312062 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 7072449 08714729779919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention