BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 18229551 · Received November 29, 2023

    Report

    Report Number
    3006630150-2023-07415
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    November 8, 2022
    Report Date
    November 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EXACT DATE UNKNOWN, EVENT OCCURRED ABOUT A YEAR AGO FROM DATE MANUFACTURER WAS MADE AWARE. D6B: EXPLANT DATE: A YEAR AGO ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: 5132869/7070182.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE NOT RELEASED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79496 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 365768 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention