BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8599770 · Received May 10, 2019

    Report

    Report Number
    3004209178-2019-09366
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 8, 2019
    Report Date
    May 10, 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
    IN, 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 PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF CHRONIC LOW BACK PAIN AND SPI NAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING THERAPY RELIEF AND WANTED TO MEET WITH A MANUFACTURER REPRESENTATIVE TO HAVE ADJUSTMENTS MADE. THE PATIENT TRIED TO ADJUST STIMULATION, BUT IT WOULD NOT GO ANY HIGHER. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394190 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR