BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20889250 · Received December 10, 2024

    Report

    Report Number
    3006630150-2024-08599
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 9, 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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT (S) INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7129205. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12160. MODEL: SC-1216. SERIAL: (B)(6). BATCH: 771080.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND THE INABILITY TO MOVE THEIR RIGHT LEG IN THE POST ANESTHESIA CARE UNIT (PACU) FOLLOWING THE IMPLANT OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM, AND THAT IT WAS DETERMINED TO BE PARALYSIS OF THE RIGHT SIDE. THE SYMPTOMS DEVELOPED ONE HOUR POST IMPLANT OF THE LEADS. THE DEVICES WERE EXPLANTED THE FOLLOWING DAY AND WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISCARDED BY THE FACILITY. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2533942 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7148337 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention