BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 9745842 · Received February 24, 2020

    Report

    Report Number
    3006630150-2020-00748
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5042698/5062242, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING BURNING, SHARP SENSATION AND TENDERNESS AT THE IPG AND LEAD SITE. DATABASE ANALYSIS INDICATED THAT THE BATTERY REVEALED NO ANOMALIES. THE PATIENT WAS PROVIDED WITH LIDOCAINE CREAM AND WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207540 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 356220 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention