BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 22358605 · Received June 30, 2025

    Report

    Report Number
    3006630150-2025-04969
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    November 2, 2022
    Report Date
    June 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 3035472/7072036, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DIFFICULTY AND EXTENDED CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG HAD MIGRATED, AND PATIENT HAD AN INADEQUATE STIMULATION DESPITE A REPROGRAMMING ATTEMPT. THE LEFT LEAD HAD FOUR CONTACTS THAT WERE OUT. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756727 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 367656 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention