BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 25260657 · Received May 22, 2026

    Report

    Report Number
    3006630150-2026-03400
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    February 5, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018726
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED LAST 3 WEEKS PER APPOINTMENT DATE (B)(6) 2026 BECAME AWARE OF THE EVENT. 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: 5002468 MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318 BATCH/LOT NUMBER: 37085914 MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT 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 LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587810 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-50 5004622 00191506018726

    Patients

    Seq Age Sex Outcome Treatment
    1