BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 11611789 · Received April 3, 2021

    Report

    Report Number
    3006630150-2021-01387
    Event Type
    Malfunction
    Date Received
    April 3, 2021
    Date of Event
    December 13, 2020
    Report Date
    August 11, 2021
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS STIMULATION WAS NO LONGER ADEQUATE. THE PATIENTS RIGHT LEAD HAD HIGH IMPEDANCES AND THE X-RAY RESULT APPEARED THE LEAD WAS BROKEN JUST BELOW THE ANCHOR. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT LEADS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    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: 5123690.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS STIMULATION WAS NO LONGER ADEQUATE. THE PATIENTS RIGHT LEAD HAD HIGH IMPEDANCES AND THE X-RAY RESULT APPEARED THE LEAD WAS BROKEN JUST BELOW THE ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509032 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5118027 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention