BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 11388296 · Received February 26, 2021

    Report

    Report Number
    3006630150-2021-00662
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    January 31, 2021
    Report Date
    February 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729820741
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED DURING THE TRIAL PERIOD. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEAD, UPN: (B)(4), MODEL: SC-2218-70E, SERIAL: (B)(4), BATCH: 7073306.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A NEW PAIN IN THE HEAD DURING A TRIAL PERIOD. THE PATIENT HAD AN EARLY LEAD PULL AND WAS HOSPITALIZED. EXPLANTED LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283088 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70E 7073267 08714729820741

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention