BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 21268255 · Received January 29, 2025

    Report

    Report Number
    3006630150-2025-00271
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    January 6, 2022
    Report Date
    January 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW YEARS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. BLOCK D6B: EXPLANT DATE: FEW YEARS AGO ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI UPN: M365SC8416500 MODEL: SC-8416-50 SERIAL: (B)(6) BATCH: 7071753.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506184 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 369370 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention