BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15229532 · Received August 15, 2022

    Report

    Report Number
    3006630150-2022-04049
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    April 13, 2022
    Report Date
    September 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 5113273.

    Additional Manufacturer Narrative · 0

    SC-2218-50 (SN: (B)(6). THE RETURNED LEAD WAS ANALYZED AND SHOWED THAT ALL WIRES WERE FRACTURED AT THE CLIK SITE, ABOUT 22.5 CENTIMETERS FROM THE PROXIMAL END. THE CABLE FRACTURES WERE A RESULT OF EXCESSIVE MECHANICAL/TENSILE FORCE EXERTED ONTO THE LEAD. THE LEAD GOT KINKED AFTER IT EXITED THE CLIK ANCHOR OR THE RIGID RETENTION SLEEVE WHICH RESULTED IN THE IMPEDANCE ANOMALY AND LEAD MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF PARESTHESIA COVERAGE DUE TO LEAD MIGRATION AND HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF PARESTHESIA COVERAGE DUE TO LEAD MIGRATION AND HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166417 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5112051 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention