BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 21058483 · Received January 2, 2025

    Report

    Report Number
    3006630150-2024-09224
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    December 9, 2023
    Report Date
    January 2, 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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D6B: EXPLANT DATE: 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740. MODEL: SC-2408-74, SERIAL: (B)(6), BATCH: 7070742/7070772. PRODUCT FAMILY: SCS-LEAD FIXATION-MRI, UPN: M365SC43190, MODEL: SC-4319, BATCH: 26073914.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN UNKNOWN ADDITIONAL BACK SURGERY, AND THE SPINAL CORD STIMULATOR (SCS) WERE REMOVED. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910378 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 370255 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention