BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 11397825 · Received March 2, 2021

    Report

    Report Number
    3006630150-2021-00695
    Event Type
    Injury
    Date Received
    March 2, 2021
    Date of Event
    January 7, 2021
    Report Date
    October 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE STIMULATION COVERAGE DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE BOTH LEADS WERE REPLACED. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4) MODEL: SC-2218-50 SERIAL: (B)(4). BATCH: 7072750

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE STIMULATION COVERAGE DUE TO LEAD MIGRATION AS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296924 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7072592 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention