BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 8720502 · Received June 20, 2019

    Report

    Report Number
    3006630150-2019-02945
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8416-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7010966, MODEL/CATALOG DESCRIPTION: ARTISAN MRI PADDLE LEAD 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SWELLING AT THE IPG SITE. THE PHYSICIAN BELIEVED THAT THE IPG MIGHT BE PUSHING ON THE NERVES. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514038 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 352431 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention