BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22870155 · Received August 22, 2025

    Report

    Report Number
    3006630150-2025-06744
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7163255. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT'S IMPLANT PROCEDURE, THE PHYSICIAN BELIEVED THAT A WET TAP OCCURRED AND PERFORMED A BLOOD PATCH. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY AND THE PATIENT DID NOT HAVE ANY OTHER ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558029 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7157194 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention