BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 16475691 · Received March 2, 2023

    Report

    Report Number
    3006630150-2023-00982
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    December 9, 2022
    Report Date
    March 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7072022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN ONE OF THE LEADS WAS REMOVED AND THE OTHER ONE WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS NOT RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731785 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7072021 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention