BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 22479181 · Received July 11, 2025

    Report

    Report Number
    3006630150-2025-05405
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 17, 2025
    Report Date
    August 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018733
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. BLOCK D2B: PRO CODE (PRODUCT CODE): QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2318700, MODEL: SC-2318-70, SERIAL: (B)(6), BATCH: 5003422, UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD OOZING IN THE LOWER BACK, SWELLING AND DISCOMFORT OR PAIN. SUBSEQUENTLY, IT WAS DISCOVERED THAT THE PATIENTS LEAD WAS EXPOSED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED. THE PHYSICIAN ORDERED ANTIBIOTICS TO CONTINUE CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD OOZING IN THE LOWER BACK, SWELLING AND DISCOMFORT OR PAIN. SUBSEQUENTLY, IT WAS DISCOVERED THAT THE PATIENTS LEAD WAS EXPOSED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED. THE PHYSICIAN ORDERED ANTIBIOTICS TO CONTINUE CARE. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT'S SYMPTOMS WERE NOT PROCEDURE RELATED, HOWEVER, THE CAUSE WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT HAD A FALL WHERE THEY SUSTAINED A FRACTURED FEMUR AND SPENT SOME TIME IN THE HOSPITAL. INFECTION WAS SUSPECTED TO HAVE ORIGINATED FROM THAT INCIDENT. MAGNETIC RESONANCE IMAGING (MRI) DID NOT SHOW ANY ISSUES WITH SPINAL CORD STIMULATOR (SCS). THE PATIENT WAS DOING WELL UPON FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678481 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-70 5002612 00191506018733

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention