BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 24916467 · Received April 17, 2026

    Report

    Report Number
    3006630150-2026-02429
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    February 19, 2026
    Report Date
    April 17, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018733
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED FEW WEEKS AFTER THEIR IMPLANT. BLOCK D2B: PRO CODE (PRODUCT CODE): QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2318-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5002563, MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IMAGING CONFIRMED THAT THE SPINAL CORD STIMULATION (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPOSITION PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. NOTHING REMOVED OR ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95186 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-70 5004655 00191506018733

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention