BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 18773854 · Received February 23, 2024

    Report

    Report Number
    3006630150-2024-00961
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: 7230796.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE TRIAL PERIOD, THE PATIENT NOTED THAT ONE OF THE BANDAGES ROLLED UP AND THEN HAD IT PLACED OVER THE LEAD SUTURES. WHEN THE PHYSICIAN INSPECTED THE SITE, THE INSERTION HOLE WAS BLEEDING MINIMALLY. DUE TO EXPOSURE, AN INFECTION DEVELOPED AND IT WAS NOT DEVICE RELATED. THE PHYSICIAN DETERMINED TO PULL THE LEADS EARLY TO REDUCE INFECTION. THE PATIENT WAS PUT ON ANTIBIOTICS AND THE LEADS WERE DISCARDED. UPON FOLLOW-UP WITH PATIENT, THE INFECTION APPEARED TO BE CLEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260029 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7230674 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention