BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 8135617 · Received December 5, 2018

    Report

    Report Number
    3006630150-2018-62109
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 5, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5063091 / 5065455, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS CONDITION HAD WORSENED AND IT WAS NOT DUE TO INADEQUATE STIMULATION. IT WAS NOTED THAT THE PATIENT WAS NON-COMPLIANT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975879 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 355714 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention