BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 20582615 · Received October 31, 2024

    Report

    Report Number
    3006630150-2024-07457
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC231670E0, MODEL: SC-2316-70E, SERIAL: (B)(6), BATCH: 7082419.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) TRIAL PROCEDURE THE PATIENT WAS EXPERIENCING PAIN. THE PATIENT UNDERWENT A SCS LEAD PULL, AND THE EXPLANTED LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065690 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2316-50E 7253876 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention