BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8659487 · Received May 31, 2019

    Report

    Report Number
    3004209178-2019-10639
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 11, 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
    MN, US
    Reporter Occupation
    OTHER

    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

    INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. INFORMATION WAS REPORTED THAT THE REP WAS MEETING WITH THE PATIENT BECAUSE THE PATIENT WASN'T GETTING PAIN RELIEF THAT HE NEEDS, AND WOULD LIKE TO BE REPROGRAMMED. THE PATIENT'S CURRENT SETTINGS FOR GROUP A ARE: 6- 5- 4+ 3+, 300 PW, 800 HZ; B: 12+ 14- 300 PW, 800 HZ. AFTER REPROGRAMMING THEIR SETTINGS ARE: 11+ 12+ 14- 15-, 300 PW, 800 HZ; B: 15- 14- 13+ 12+ 300 PW, 800 HZ. THE PATIENT IS NOT ABLE TO INCREASE STIMULATION PAST 0.6 MA BEFORE GETTING OUT OF REGULATION (OOR). THE PATIENT'S IMPEDANCES WERE MEASURE WITH THE FOLLOWING RESULTS (OHMS): 1 1150 2 1120 3 1260 4 1450 5 1140 6 1170 7 1330 8 1210 9 1160 10 1150 11 1370 12 1200 13 1170 14 1230 15 13600 THE REP STATED THE INITIAL IMPEDANCE TEST SHOWED IMPEDANCES IN THE 3K OHMS RANGE. THE REP WAS ADVISED TO NOT USE ELECTRODE 15 SINCE THE IMPEDANCES WERE HIGHER. THE REP REPROGRAMMED THE PATIENT USING HIGH DENSITY (HD) SETTINGS, AND NOTED THAT IT MIGHT BE A FEW HOURS BEFORE THE PATIENT GETS RELIEF DUE TO THE HD SETTINGS. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WERE NOT DETERMINED. AFTER REPROGRAMMING THE PATIENT IS GETTING MUCH BETTER RELIEF. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454119 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR