BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 14602290 · Received June 6, 2022

    Report

    Report Number
    3006630150-2022-02704
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 6, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7071174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT A LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION. LEAD MIGRATION WAS CONFIRMED BY X-RAY. THE LEADS WERE REPOSITIONED AND THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158480 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 5027907 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention