BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 14029705 · Received April 6, 2022

    Report

    Report Number
    3006630150-2022-01498
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    February 15, 2022
    Report Date
    July 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT HAD OCCURRED IN THE PAST MONTH FROM THE DATE THE MANUFACTURER BECAME AWARE.

    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: 7072791/7072797.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT DUE TO THE RASH AND BLISTERS AROUND THE IPG SITE. THE PHYSICIAN PRESCRIBED AN OINTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT DUE TO THE RASH AND BLISTERS AROUND THE IPG SITE. THE PHYSICIAN PRESCRIBED AN OINTMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO NOT GETTING ADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND ALL DEVICE COMPONENTS WILL NOT BE RETURNED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695522 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 366387 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention