BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20593325 · Received November 1, 2024

    Report

    Report Number
    3006630150-2024-07512
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    June 1, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7140844.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED CAUSING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED CAUSING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176586 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7139928 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention