BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11904828 · Received May 28, 2021

    Report

    Report Number
    3006630150-2021-02499
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 28, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7123070.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TRIAL PROCEDURE AND EXPERIENCED SEVERE MIGRAINE PAIN WHEN STIMULATION WAS ON AND IMPEDANCE IRREGULARITIES WERE NOTED. THE PHYSICIAN NOTED A CEREBROSPINAL FLUID. NO MEDICAL INTERVENTION WAS PROVIDED, AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799359 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7122470 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention