BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10189240 · Received June 24, 2020

    Report

    Report Number
    3006630150-2020-02592
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    June 11, 2020
    Report Date
    June 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5072624, 5094485, 5117138.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT WHEN SHE TURNED HER HEAD. ONE OF THE LEADS MOVED SLIGHTLY AND WAS HIGHER THAN THE OTHER LEADS. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE PHYSICIAN REPOSITIONED THE LEAD. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654026 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 21644252 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention