BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18536054 · Received January 18, 2024

    Report

    Report Number
    3006630150-2024-00109
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    August 7, 2023
    Report Date
    February 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7085714. PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160. MODEL: SC-1415. SERIAL: (B)(6). BATCH: 203166.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. IT WAS NOTED THAT THE PATIENTS LEFT LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG AND LEADS WERE REPLACED. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. IT WAS NOTED THAT THE PATIENTS LEFT LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG AND LEADS WERE REPLACED. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR IPG REPLACEMENT WAS DUE TO PHYSICIANS PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829656 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7085771 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention