BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 18935809 · Received March 19, 2024

    Report

    Report Number
    3006630150-2024-01606
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 19, 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: 7203365.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEFT LEAD INSERTION AREA AFTER A LEAD PULL PROCEDURE. SYMPTOMS OF REDNESS, PAIN AND HEADACHE WERE NOTED. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED TO THE HOSPITAL FOR EVALUATION. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS TREATED FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. NOTHING HAPPENED DURING THE RECENT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO INFECTION. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754586 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7202686 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| H