BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17998821 · Received October 24, 2023

    Report

    Report Number
    3006630150-2023-06504
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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)(6), BATCH: 7111283. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12160, MODEL: SC-1216, SERIAL: (B)(6), BATCH: 545164.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED. IT WAS NOTED ALSO THAT PATIENT EXPERIENCE PAIN AT THE POCKET AREA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE BOTH LEADS AND IPG WAS REMOVED. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS NOT RELEASED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812710 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7111092 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Required Intervention