BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22200864 · Received June 13, 2025

    Report

    Report Number
    3006630150-2025-04391
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    March 27, 2025
    Report Date
    June 13, 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
    UT, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7153259. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14160. MODEL: SC-1416. SERIAL: (B)(6). BATCH: 230845. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS MIGRATED DRASTICALLY PER IMAGING TAKEN, AND THE PATIENT COULD NOT GET STIMULATION ON OTHER PAIN AREAS DESPITE OF OPTIMIZING THE PROGRAM. IT WAS ALSO NOTED THAT THE PATIENT HAD A FALL THAT LED TO A SORE THAT WAS BLEEDING ON THE MEDIAL SIDE OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552296 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7152919 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention