BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 24019374 · Received January 9, 2026

    Report

    Report Number
    3006630150-2026-00217
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8416500. MODEL: SC-8416-50. SERIAL: (B)(6). BATCH: 7071235. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) WAS NO LONGER WORKING AS INTENDED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87762 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 370814 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention