BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 13103211 · Received December 29, 2021

    Report

    Report Number
    3006630150-2021-07325
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    December 8, 2021
    Report Date
    January 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH/LOT: 7092004.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION. X-RAY WAS TAKEN AND SHOWED THAT THE LEAD MIGRATED DOWN NEAR THE BATTERY POCKET. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE DISPOSED BY FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION. X-RAY WAS TAKEN AND SHOWED THAT THE LEAD MIGRATED DOWN NEAR THE BATTERY POCKET. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004256 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7089333 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention