BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 19494150 · Received June 8, 2024

    Report

    Report Number
    3006630150-2024-03688
    Event Type
    Injury
    Date Received
    June 8, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7243868.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A POST OP TRIAL PROCEDURE THE PATIENT WAS EXPERIENCING INTENSE PAIN IN THE LEFT LEG, DESPITE ATTEMPTS WITH MEDICATION. XRAY CAME BACK NORMAL, BUT THE PATIENT WAS STILL IN PAIN. IT WAS UNKNOWN IF THE PAIN WAS DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT A LEAD PULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318951 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7239190 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention