BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11884501 · Received May 26, 2021

    Report

    Report Number
    3006630150-2021-02402
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7111641.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE LEG PAIN. IT WAS NOTED THAT THE MRI IMAGING SHOWED EPIDURAL HEMATOMA IN THE THORACIC AREA. THE PHYSICIAN WAS WORRIED THAT THE HEMATOMA WAS CAUSED BY THE TRIAL PROCEDURE. THE PATIENT UNDERWENT A LEAD REMOVAL PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784021 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7111365 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention