BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11712710 · Received April 23, 2021

    Report

    Report Number
    3006630150-2021-01736
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    July 16, 2020
    Report Date
    April 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7073634/7074889.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT WITH THE LOCATION OF THE IPG DESPITE REPROGRAMMING DONE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609843 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 364964 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention