BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 12125410 · Received July 6, 2021

    Report

    Report Number
    3006630150-2021-03565
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    March 16, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED FEW MONTHS THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: (B)(4). MODEL: SC-2408-56 SERIAL: (B)(4). BATCH: 5173793 / 5173791.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SEVERE PAIN AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022510 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 365697 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention