BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 22947013 · Received September 2, 2025

    Report

    Report Number
    3006630150-2025-07132
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    May 6, 2025
    Report Date
    September 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018726
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2318500, MODEL: SC-2318-50, SERIAL: (B)(6), BATCH: 5001810, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO LEAD MIGRATION WHICH WAS CONFIRMED THROUGH X-RAY. DURING THE LEAD REVISION PROCEDURE, A LEAD WAS REPLACED AS IT WAS DAMAGED WHEN THE PHYSICIAN WAS TRYING TO ACCESS AND REPOSITION IT. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991610 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-50 5001129 00191506018726

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention