BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17713686 · Received September 8, 2023

    Report

    Report Number
    3006630150-2023-05420
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    April 14, 2023
    Report Date
    September 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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), LOT: 7102312. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), LOT: 7121683. PRODUCT FAMILY: UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), LOT: 7122086.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENTS SPINAL CORD STIMULATION LEADS MIGRATED AND THE PATIENT EXPERIENCED STIMULATION RELATED DISCOMFORT IN THE RIB CAGE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE FOUR PERCUTANEOUS LEADS WERE REMOVED AND A PADDLE LEAD WAS IMPLANTED. THE PATIENT RECEIVED STIMULATION COVERAGE OF ALL PAIN AREAS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664128 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7103100 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention