BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10154689 · Received June 15, 2020

    Report

    Report Number
    3006630150-2020-02466
    Event Type
    Injury
    Date Received
    June 15, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURED IN (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7076054. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7071036/7071471.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED AND THE PATIENT WAS EXPERIENCING STIMULATION ON NON TARGET AREAS. THE PATIENTS FOUR LINEAR LEADS WERE REPLACED WITH TWO PADDLE LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615813 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7074743 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention