BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22170998 · Received June 9, 2025

    Report

    Report Number
    3006630150-2025-04092
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    April 24, 2025
    Report Date
    August 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7162269. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE TO ADDRESS LEADS MIGRATION, AS CONFIRMED BY X-RAY IMAGING. THE PATIENT UNDERWENT A LEADS REVISION PROCEDURE WHEREIN THEIR LEADS WERE EXPLANTED AND REPLACED. THE LEADS WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS REPORTED AS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE TO ADDRESS LEADS MIGRATION, AS CONFIRMED BY X-RAY IMAGING. THE PATIENT UNDERWENT A LEADS REVISION PROCEDURE WHEREIN THEIR LEADS WERE EXPLANTED AND REPLACED. THE LEADS WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS REPORTED AS STABLE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AS A CONSEQUENCE OF LEADS MIGRATION, THE PATIENT EXPERIENCED STIMULATION OUTSIDE OF THEIR TYPICAL PAIN PATTERN, AS WELL AS PAINFUL SENSATIONS AT THE END OF THE LEADS LOCATION DURING REPROGRAMMING ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307631 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7162167 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention