BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 11311187 · Received February 10, 2021

    Report

    Report Number
    3006630150-2021-00412
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 10, 2021
    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: 7072053.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POKING PAIN AT THE LEFT LEAD SITE WHEN SITTING IN A CHAIR AND OR WHEN THERE WAS PRESSURE PLACED ON THE AREA. THE PATIENT DID INDICATE THAT THE STIMULATION WAS PROVIDING ADEQUATE STIMULATION FOR WHICH IT WAS IMPLANTED. THE PHYSICIAN ASSESSED THAT THE CAUSE OF THE PATIENTS PAIN WAS THE PROGRESSION OF HER SCOLIOSIS OF THE SPINE. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEFT LEAD WAS REPOSITIONED BY BEING PULLED DOWN. THE PATIENT IS DOING WELL POST OPERATIVELY AND THE POKING PAIN HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206416 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7072167 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention