BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8588002 · Received May 7, 2019

    Report

    Report Number
    3006630150-2019-02120
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 8, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 231607, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE DUE TO A NEED FOR MAGNETIC RESONANCE IMAGING (MRI). SUBSEQUENTLY, A LIPOMA WAS NOTED ON THE PATIENTS BACK. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE PHYSICIAN ATTEMPTED TO REMOVE THE LIPOMA, HOWEVER, ONLY A PARTIAL WAS REMOVED AS A LEAD WAS DISCOVERED TO BE INTERTWINED IN THE LIPOMA. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN LEADS WILL BE REPLACED AND A NEW IPG WILL BE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380036 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 229000 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention