BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 21939860 · Received April 30, 2025

    Report

    Report Number
    3006630150-2025-02949
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    February 4, 2025
    Report Date
    April 30, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY SEVERAL WEEKS FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7070825, UDI:(B)(4_. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7070830, UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. TH PATIENT UNDERWENT A SCS REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190999 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 370321 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention