BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 9336312 · Received November 18, 2019

    Report

    Report Number
    3006630150-2019-06600
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 29, 2019
    Report Date
    November 18, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: LINEAR ST LEAD KIT 50 CM. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 5173019. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PRESSURE AND PAIN WHICH IS SUSPECTED TO BE CAUSED BY THE LEADS. IT WAS NOTED THAT THE PATIENT ALSO HAD EYE TWITCHES, EYE TEARING AND PRESSURE IN THE RIGHT CHEEK. IT WAS CONFIRMED THROUGH X-RAY THAT THE PATIENTS SUPRAORBITAL LEAD HAD MIGRATED. THE PATIENT WAS PRESCRIBED WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131572 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5173036 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention