BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 9668137 · Received February 4, 2020

    Report

    Report Number
    3006630150-2020-00369
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 4, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5170366.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT FROM THE LEADS BEING PLACED TOO SHALLOW. THE PHYSICIAN TOOK IMAGES AND CONFIRMED THE DISCOMFORT WAS NOT DUE TO LEAD MIGRATION. THE PHYSICIAN DECIDED TO PERFORM A REVISION PROCEDURE TO REPOSITION THE LEADS. PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129623 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 5170366 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention