BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 19080311 · Received April 10, 2024

    Report

    Report Number
    3006630150-2024-02232
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    January 1, 2022
    Report Date
    April 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED IN 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216500. MODEL: SC-8216-50. SERIAL: (B)(6). BATCH: 7023698.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LESS EFFECTIVENESS OF THE STIMULATION DESPITE MULTIPLE REPROGRAMMING. THE PATIENT UNDERWENT EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED PER HOSPITAL POLICY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428007 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 374183 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention