BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11112334 · Received January 4, 2021

    Report

    Report Number
    3006630150-2020-06541
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 4, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7072108/7073857.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE RIGHT BEFORE THE IPG WAS IMPLANTED, THE PATIENTS BLOOD PRESSURE WAS DROPPING. THE PHYSICIAN BELIEVED THAT THE PATIENTS SYMPTOMS WERE NOT DEVICE NOR PROCEDURE RELATED HOWEVER, DUE TO PATIENT BEING DEHYDRATED AND COULD NOT HANDLE THE ANESTHESIA. THE PROCEDURE WAS ABORTED AND ALL DEVICES WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5408 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 372855 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention