BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 14792904 · Received June 23, 2022

    Report

    Report Number
    3006630150-2022-03074
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    May 21, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 7073003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INTERMITTENT DISCOMFORT AND FELT SWELLING AROUND THE LEAD IN THE BACK OF THE HEAD. THE PATIENT WAS PLACED ON CIPRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983556 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7073015 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention