BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 22135107 · Received June 3, 2025

    Report

    Report Number
    3006630150-2025-03904
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7080563, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 587803, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7077812, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180, MODEL: SC-4318, BATCH: 31853961, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED AN INFECTION AT THE LEAD INSERTION WOUND SITE RESULTING IN REDNESS AROUND THE AREA IN THE LOW BACK. A CULTURE WAS TAKEN WHICH CONFIRMED THE PRESENCE OF STAPHYLOCOCCUS AUREUS. THE PATIENT WAS GIVEN ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE SCS SYSTEM WAS REMOVED. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889463 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2366-50 7080460 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention