BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10203658 · Received June 26, 2020

    Report

    Report Number
    3006630150-2020-02664
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 26, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS LINEAR LEADS; UPN: M365SC2218700; MODEL: SC 221870; SERIAL: (B)(4); BATCH: 5092156.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS CERVICAL LEADS APPEARED TO HAVE MIGRATED AND JUST COVERING THE RIGHT SIDE AT LOWER LEVEL. THE PHYSICIAN REPOSITIONED THE EXISTING LEADS AND PLACED AN ADDITIONAL LEAD ON THE LEFT SIDE OF THE SPINE. THE PATIENT HAS GREAT COVERAGE BILATERALLY AND WAS VERY PLEASED WITH THE NEW COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663420 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5060497 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention