BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11580732 · Received March 29, 2021

    Report

    Report Number
    3006630150-2021-01257
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7072552/7072554.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS ALSO REPORTED THAT THE PATIENT HAS HAD MULTIPLE MEDICAL COMPLAINTS INCLUDING ITCHING, RASHES, SWELLING, VOMITING, NAUSEA, AND HAD ONE EPISODE OF CHEST PAIN. THE PATIENT WAS PRESCRIBED WITH MEDROL DOSEPAK MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480057 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 374748 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention