BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 18923010 · Received March 18, 2024

    Report

    Report Number
    3006630150-2024-01549
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN FEBRUARY 2024 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7082400.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED SIGNS OF INFECTION SUCH AS REDNESS AND ITCHING AT THE LEAD INSERTION SITE. THE INFECTION WAS TREATED WITH ANTIBIOTICS AND THE PATIENTS SYMPTOMS HAVE IMPROVED. THE SCS SYSTEM REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181129 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7082401 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention