BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 17179117 · Received June 22, 2023

    Report

    Report Number
    3006630150-2023-03589
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 1, 2023
    Report Date
    August 24, 2023
    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

    EXACT DATE UNKNOWN, EVENT OCCURRED A MONTH AGO.

    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)(6) BATCH: 7091488.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN X-RAY PERFORMED WHICH SHOWED A BROKEN LEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN X-RAY PERFORMED WHICH SHOWED A BROKEN LEAD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT WILL UNDERGO REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS NOT RELEASED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN X-RAY PERFORMED WHICH SHOWED A BROKEN LEAD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT WILL UNDERGO REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306785 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7092510 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention