BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 21776305 · Received April 4, 2025

    Report

    Report Number
    3006630150-2025-02170
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 8, 2021
    Report Date
    April 4, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED FOUR WEEKS AFTER THE DATE OF IMPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8416500, MODEL: SC-8416-50, SERIAL: (B)(6), BATCH: 7043397, UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. SYMPTOMS OF PAIN, REDNESS AND SWELLING AT THE IPG SITE WERE NOTED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICE COMPONENTS WERE REMOVED. IT WAS BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT FULLY RECOVERED, AND THE EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333620 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 370178 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention