BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19534656 · Received June 14, 2024

    Report

    Report Number
    3006630150-2024-03838
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR ST, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6) , BATCH: 7091432. BRAND NAME: WAVEWRITER ALPHA, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6) , BATCH: 752935.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND PAIN ACROSS HIS UPPER AND LOWER LIMBS AFTER THE IMPLANT OF THE LEADS AND IMPLANTABLE PULSE GENERATOR (IPG) OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED AND FOUND NO ABNORMALITIES. THE PHYSICIAN DECIDED TO EXPLANT THE ENTIRE SYSTEM DUE TO CONCERNS OF SPINAL CORD COMPRESSION. THE PATIENTS' SYMPTOM HAVE IMPROVED POST EXPLANT, AND IS DOING WELL. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372670 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7086612 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention