BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 8011452 · Received October 28, 2018

    Report

    Report Number
    3006630150-2018-61549
    Event Type
    Injury
    Date Received
    October 28, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 26, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER : (B)(4); BATCH/LOT NUMBER: 5020669; 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 PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. IT WAS NOTED THAT DURING IMPLANT OF NEW SYSTEM, PATIENTS LOWER EXTREMITIES WERE NOT SHOWING NORMAL. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE RELATED AND THE CAUSE WAS UNKNOWN. THE CASE WAS ABORTED PER PHYSICIANS PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852997 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 352182 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention