BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 22473687 · Received July 10, 2025

    Report

    Report Number
    3006630150-2025-05356
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 3, 2025
    Report Date
    July 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729797821
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. BRAND NAME: INFINION 16. UPN: M365SC2316700. MODEL: SC-2316-70. SERIAL: (B)(6). LOT: 7091197. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SPINAL CORD STIMULATION (SCS) TRIAL LEAD TEST PERIOD, THE PATIENT EXHIBITED REDNESS WITH AN ALLERGIC REACTION TO THE IMPLANTED LEADS. THE PATIENT UNDERWENT AN EARLY TRIAL LEAD PULL DUE TO THE REACTION. THE PATIENT HAS SINCE RECOVERED AND NO LONGER HAS SYMPTOMS. THE TRIAL LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120510 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2316-70 7084458 08714729797821

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention