BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 22951902 · Received September 3, 2025

    Report

    Report Number
    3006630150-2025-07155
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    January 21, 2025
    Report Date
    September 18, 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
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8416700. MODEL: SC-8416-70. SERIAL: (B)(6). BATCH: 7060366. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450537 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 366663 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention