BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 11477389 · Received March 12, 2021

    Report

    Report Number
    3006630150-2021-00935
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    September 30, 2020
    Report Date
    March 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED FEW WEEKS AGO FROM THE PERMANENT IMPLANT DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7070669.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NECK AND HEAD TENSION FOLLOWING A PERMANENT IMPLANT PROCEDURE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE SUTURE SLEEVES WERE REMOVED OFF OF THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365457 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7070591 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention