BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8744168 · Received June 28, 2019

    Report

    Report Number
    3006630150-2019-03140
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 10, 2019
    Report Date
    October 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT PER BSN SALE REPRESENTATIVE, THE PATIENT HAS NOT BEEN EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND WERE DISCARDED BY FACILITY.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT UNDERWENT AN EXPLANT PROCEDURE AS PER NEW UPDATE FROM THE BSN SALES REPRESENTATIVE AND HAD MISUNDERSTOOD THE PATIENTS PREVIOUS STATEMENT. THE PATIENT WAS STILL CURRENTLY IMPLANTED WITH THE DEVICES AND WILL UNDERGO AN EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: 0301110000-2019-8009, BATCH/LOT NUMBER: 250326/251414, MODEL/CATALOG DESCRIPTION:LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540153 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 13440310 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention