BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10497395 · Received September 4, 2020

    Report

    Report Number
    3006630150-2020-03947
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    August 14, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. THEREFORE NO PROBLEM WAS DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. IT WAS NOTED THAT THE PATIENT DEVELOPED A FISTULA AT THE IPG SITE WITH A SMALL AMOUNT OF DRAINAGE. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ONLY THE IPG WAS EXPLANTED. EXPLANTED IPG WILL BE RETURNED. CULTURES WERE TAKEN AND THE RESULT REVEALED NEGATIVE OF INFECTION. THE PATIENT "HAS" A HISTORY OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 5149581/5150717.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. IT WAS NOTED THAT THE PATIENT DEVELOPED A FISTULA AT THE IPG SITE WITH A SMALL AMOUNT OF DRAINAGE FROM THE OPENING. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND REPROGRAMMING ATTEMPT WAS UNSUCCESSFUL. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ONLY THE IPG WAS EXPLANTED. EXPLANTED IPG WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957434 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 366816 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention