BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 21421089 · Received February 20, 2025

    Report

    Report Number
    3006630150-2025-00882
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    November 25, 2021
    Report Date
    February 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR AFTER THE DEVICE WAS IMPLANTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8416700, MODEL: SC-8416-70, SERIAL: (B)(6), BATCH: 7070575.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) WAS CAUSING NUMBNESS ON THE PATIENTS RIGHT ARM AND HAND WHEN IT SHOULD BE HELPING WITH THE PAIN ON THE LEFT ARM. THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028383 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 370080 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention