BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 22163630 · Received June 7, 2025

    Report

    Report Number
    3006630150-2025-04056
    Event Type
    Injury
    Date Received
    June 7, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL:SC-2352-70, SERIAL: (B)(6), BATCH:7083664, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE. SYMPTOM OF ITCHING AT THE SITE WAS NOTED AND PART OF THE LEAD WAS ALSO STICKING OUT. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN EXPLANT PROCEDURE. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. 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
    1392846 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-70 7083651 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female Required Intervention| H