BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 10179886 · Received June 22, 2020

    Report

    Report Number
    3004209178-2020-10764
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 18, 2020
    Report Date
    June 26, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE IMPEDANCE ISSUE WAS RECURRING AND REASON WAS UNKNOWN. REP WAS ABLE TO PROGRAM AROUND THE IMPEDANCES, ISSUE NOT RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). INFORMATION WAS REPORTED THAT THE CALLER WAS PROGRAMMING WITH THE PATIENT'S DEVICE AND MADE SOME SETTINGS CHANGES. WHEN THEY ENDED THE SESSION THE PATIENT WAS GETTING THE SETTINGS NOT AVAILABLE MESSAGE ON THE PATIENT CONTROLLER. THE CALLER PROVIDED THE FOLLOWING IMPEDANCE INFORMATION FROM THE TABLET: REF 0 12 40000 13 40000, REF 11 14 940 15 880, REF 9 10 820, REF 1 2 770, REF 13 14 40000 15 40000, REF 14 15 810. THE PATIENT WAS PROGRAMMED WITH GROUP A AND GROUP B. THE CALLER INDICATED THAT THEY WERE GETTING THE OOR MESSAGE ON BOTH GROUPS. THE CALLER PROVIDED THE FOLLOWING THERAPY PROGRAMMING INFORMATION: A1 ACTIVE ELECTRODES 13 14 15, INTENSITY: 1.5MA PW: 510US, RATE: 25 A2, ACTIVE ELECTRODES 1 2, INTENSITY: 1.6MA PW: 180, RATE: 25 A3 ,ACTIVE ELECTRODES 9 10, INTENSITY: 1.1MA PW: 180, RATE: 25 A4, ACTIVE ELECTRODES 11 14 15, INTENSITY: 1.2MA PW: 520US, RATE: 25HZ. THE CALLER REMOVED THE 13 ELECTRODE FROM PROGRAM A1, AND WAS NOT GETTING THE OOR MESSAGE ANY LONGER. THE PATIENT INDICATED THAT HE COULD FEEL STIMULATION AS THE REP INCREASED THE INTENSITY ON PROGRAM A1. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645494 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR