BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8593483 · Received May 8, 2019

    Report

    Report Number
    3006630150-2019-02132
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 20, 2016
    Report Date
    May 8, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-8416-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7041771, MODEL/CATALOG DESCRIPTION: ARTISAN MRI PADDLE LEAD 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385888 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 16160383 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention