BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 15973768 · Received December 13, 2022

    Report

    Report Number
    3006630150-2022-06974
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7180756.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING EXCRUCIATING NECK AND HEAD PAIN FOLLOWING A TRIAL PROCEDURE. IT WAS NOTED THAT THE SYMPTOMS WERE POSSIBLE SIGNS OF CEREBROSPINAL FLUID LEAKAGE (CSF). A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS TAKEN, AND THE RESULT SHOWED THAT THERE WAS AN EXCESS AIR IN THE EPIDURAL SPACE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ALSO UNDERWENT A LEAD PULL PROCEDURE. THE PATIENTS NECK AND HEAD PAIN SUBSIDED AND WAS DOING BETTER. THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142522 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7177282 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| H