BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 8147684 · Received December 10, 2018

    Report

    Report Number
    3006630150-2018-62173
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    November 2, 2018
    Report Date
    December 10, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8416-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7014080, MODEL/CATALOG DESCRIPTION: ARTISAN MRI PADDLE LEAD 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN SCS REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985487 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 353423 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention