BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 13825289 · Received March 19, 2022

    Report

    Report Number
    3006630150-2022-01107
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    March 2, 2022
    Report Date
    October 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED A DAY BEFORE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7083400/7083514. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5037938/7070019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PERSISTENT PAIN AND DISCOMFORT AT THE IPG SITE. INADEQUATE STIMULATION WAS ALSO REPORTED. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PERSISTENT PAIN AND DISCOMFORT AT THE IPG SITE. INADEQUATE STIMULATION WAS ALSO REPORTED. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEADS HAD MIGRATED AND WAS CONFIRMED VIA X-RAY. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006575 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 366301 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention