BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8704330 · Received June 17, 2019

    Report

    Report Number
    3004209178-2019-11716
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 10, 2019
    Report Date
    June 17, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN AND CHRONIC LOW BACK PAIN. IT WAS REPORTED THAT IN THE MIDDLE OF THE NIGHT THE DEVICE CUTS OFF. WHEN THE PATIENT WAKES UP, THEY ARE IN A LOT OF PAIN BECAUSE THE DEVICE WAS NOT ON. THE PATIENT SAID THEY CANNOT EVEN MOVE. THE PATIENT SAID THEY HAD BEEN IN PAIN SINCE 2009 DUE TO STENOSIS AND SCOLIOSIS. THE PATIENT CONFIRMED THE INS WAS CHARGED WHEN STIM TURNS OFF. THE PATIENT SAID THE ISSUE BEGAN 2-3 DAYS PRIOR TO THE REPORT AFTER A REPROGRAMMING SESSION WITH A MANUFACTURER REPRESENTATIVE WHO CHANGED THE PATIENT'S INS SETTINGS INCLUDING ADDING ADAPTIVE STIMULATION. THE PATIENT CONFIRMED THEY NOTICED THE STIM TURNED OFF WHEN LAYING ON HIS BACK OR SIDE. THE PATIENT WAS ASSISTED WITH TURNING ADAPTIVE STIMULATION OFF. THE PATIENT CONFIRMED THE CURRENT ACTIVE GROUP WAS A WITH PROGRAMS 1 AND 2. THE ISSUE WAS REPORTED TO BE RESOLVED. THE PATIENT CALLED BACK AND STATED THEY WERE ABLE TO RESOLVE THE STIM CUTTING OFF, HOWEVER, THE PATIENT STILL WOKE UP IN PAIN AND NOT BEING ABLE TO MOVE OR WALK. THE PATIENT SAID IT TAKES 10 MINUTES TO BE ABLE TO MOVE AROUND. THE PATIENT WAS DIRECTED TO FOLLOW UP WITH THEIR HCP TO ADDRESS THE PAIN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497752 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR