BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 19037846 · Received April 3, 2024

    Report

    Report Number
    3006630150-2024-02048
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN THE LAST COUPLE OF DAYS OF THE TRIAL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7231020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD INSERTION SITE. SYMPTOMS OF SORENESS, NAUSEA AND SUPERFICIAL PUSS WERE NOTED. THE PHYSICIAN REMOVED THE LEADS, CLEANED UP THE SITE AND PRESCRIBED ANTIBIOTICS. IT WAS BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENTS INFECTION HAS CLEARED UP AND THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546116 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7230941 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention