BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22927498 · Received August 29, 2025

    Report

    Report Number
    3006630150-2025-07054
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. BRAND NAME: LINEAR? ST. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). LOT: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS BRAND NAME: LINEAR? ST UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), LOT: 7092727, UDI: (B)(4). CORRECTION TO THE INITIAL MDR IN BLOCK B5 AND H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A NON-DEVICE-RELATED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE X-RAY REVEALED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPOSITIONED. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A NON-DEVICE-RELATED SURGICAL KNEE PROCEDURE, THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE X-RAY REVEALED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPOSITIONED. POSTOPERATIVELY, THE PATIENT EXPERIENCED SWELLING, REDNESS, SEVERE PAIN IN THE NECK AND KNEE, AND WAS ADMINISTERED OXYMORPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130894 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7096741 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention