BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 14835761 · Received June 27, 2022

    Report

    Report Number
    3006630150-2022-03121
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 27, 2022
    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
    TN, 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: 7080235.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DUE TO LEAD MIGRATION AND LEAD FRACTURE. IT WAS ALSO NOTED THAT THE LEADS HAD HIGH IMPEDANCE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LINEAR LEADS WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017490 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7080203 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention