BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 14691148 · Received June 14, 2022

    Report

    Report Number
    3006630150-2022-02870
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 14, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7072990. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7073253.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION AND INADEQUATE STIMULATION. X-RAYS WERE TAKEN TO CONFIRM THE LEAD MIGRATION AND THE PATIENT'S DEVICE WAS REPROGRAMMED. THE PATIENT UNDERWENT A REVISION PROCEDURE AND ONLY THE LEADS WERE REPOSITIONED. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2870902 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7073271 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention