BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 12736660 · Received November 2, 2021

    Report

    Report Number
    3006630150-2021-06146
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    May 20, 2021
    Report Date
    November 2, 2021
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(4), BATCH: 7071025.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INFLAMMATION IN THE CERVICAL CORD REGION AND IT WAS UNCERTAIN IF IT WAS DEVICE RELATED OR NOT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED TO FREE UP CANAL SPACE. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634798 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW SC-1200 371939 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention