BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 13589907 · Received February 24, 2022

    Report

    Report Number
    3006630150-2022-00669
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 24, 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: 7091980.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED. THE LEADS WERE EXPLANTED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108125 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7091698 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention