BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 21840467 · Received April 15, 2025

    Report

    Report Number
    3006630150-2025-02488
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    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-IPG-R, UPN: M365SC1110020, MODEL: SC-1110-02, SERIAL: (B)(6), BATCH: 186201, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI/SCS-LINEAR LEADS, UPN: M365SC2138500, MODEL: SC-2138-50, SERIAL: (B)(6), BATCH: A35881/A35535, UDI: (B)(4). UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI/SCS-LINEAR LEADS, UPN: M365SC2138700, MODEL: SC-2138-70, SERIAL: (B)(6), BATCH: 134863/151382/162770, UDI: (B)(4). UDI: (B)(4). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) SYSTEM EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103819 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 351997

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention