BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION PRO

    MDR report key: 20855795 · Received December 5, 2024

    Report

    Report Number
    3006630150-2024-08429
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018726
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2318500, MODEL: SC-2318-50, SERIAL: (B)(6), BATCH: 5001454.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FOLLOWING A RECENT IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT. THE PHYSICIAN WAS CONCERN THAT THE SPINAL CORD STIMULATION (SCS) LEAD MAY BE RESTING ON A NERVE IN THE EPIDURAL SPACE CAUSING DISCOMFORT. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501681 INFINION PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-50 5001426 00191506018726

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention