BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 16665842 · Received April 3, 2023

    Report

    Report Number
    3006630150-2023-01758
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    March 2, 2023
    Report Date
    April 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: (B)(4); MODEL: SC-2316-50E; SERIAL: (B)(4); BATCH: 7190532.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT, THAT IS ENROLLED IN THE FAST CLINICAL TRIAL (B)(6), EXPERIENCED EXTREME LOW BACK PAIN, TENDERNESS AT THE LEAD ANCHOR SITE, NAUSEA AND A PHLEGMON INFECTION WHICH WAS THOUGHT TO BE SEVERE. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND HOSPITALIZED, AT WHICH TIME THE TRIAL LEADS WERE PULLED AND THE ANCHORS WERE REMOVED. THE PATIENT WAS PRESCRIBED MEDICATION FOR THE NAUSEA AND PAIN. THE PATIENT UNDERWENT AN MAGNETIC RESONANCE IMAGING (MRI) WHICH CONFIRMED EXTENSIVE PHLEGMON AND EDEMA. THE PATIENT'S CONDITION IMPROVED AND WAS DISCHARGED FROM THE HOSPITAL, HOWEVER THE EVENT REMAINS ONGOING. THE EVENT WAS ASSESSED AS HAVING A POSSIBLE RELATIONSHIP TO THE PROCEDURE AND THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878966 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7190532 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H