BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 12890648 · Received November 30, 2021

    Report

    Report Number
    3006630150-2021-06816
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    March 26, 2018
    Report Date
    November 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 3211060/20232447.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING GOOD RELIEF AND THE IPG WAS NOT CHARGING WELL. THE IPG WAS REPLACED WITH AN MRI COMPATIBLE DEVICE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS THEY IT WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791458 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 352260 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention