BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 9965546 · Received April 15, 2020

    Report

    Report Number
    3006630150-2020-01779
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 16, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5170366, ARTG: 128775.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS SUPERFICIAL, AND SHE FELT THAT IT WAS POKING HER. THE UNDERWENT A LEAD REVISION PROCEDURE IN WHICH THE LEAD WAS REPOSITIONED. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AS IT REMAINS IMPLANTED AND THE COMPLAINT AS REPORTED WAS NOT ABLE TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428496 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 5170077 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention