BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 12095461 · Received June 30, 2021

    Report

    Report Number
    3006630150-2021-03367
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    February 20, 2020
    Report Date
    June 30, 2021
    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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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: (B)(4). MODEL: SC-2218-50 SERIAL: (B)(4). BATCH: 7073649.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DUE TO LEAD MIGRATION. THE STIMULATION GOES OFF AND ON WHEN WALKING OR MAKING POSTURE CHANGES. POSITIONAL HEADACHES AND NAUSEA WERE ALSO NOTED. DATABASE ANALYSIS OF THE CHARGE PROFILE REVEALED NO ANOMALIES. THE IMPEDANCE MEASUREMENTS REVEALED HIGH VALUES ON PORT D(1 CONTACT). THE PATIENT ONLY GETS LEFT RIBS AND ABDOMEN STIMULATION. REPROGRAMMING ATTEMPT WAS DONE WITH NO RESOLUTION. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987487 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7073565 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention