BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8597194 · Received May 9, 2019

    Report

    Report Number
    3004209178-2019-09311
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 29, 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

    THE CONSUMER REPORTED THAT HE SAW THE SETTINGS NOT AVAILABLE MESSAGE WHEN HE TRIED TO INCREASE STIMULATION ON GROUPS A AND C. WHEN THE PATIENT DECREASED STIMULATION DOWN AND BACK UP IT WOULDN¿T LET HIM INCREASE AGAIN AS IT CAME UP WITH THE SETTINGS NOT AVAILABLE MESSAGE RIGHT AWAY. THE PATIENT WAS DIRECTED TO THE HEALTHCARE PROVIDER TO CHECK THE DEVICE AGAIN. FURTHER INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT SHE GOT OUT OF RANGE ON THE TABLET AND ADJUSTED THE SETTINGS TO CLEAR THE MESSAGE. THE PATIENT WAS SENT HOME AT A LEVEL BELOW THE MESSAGE AND WHEN HE USED THE CONTROLLER TO INCREASE THE MESSAGE RETURNED. THERE WERE NO ISSUES WITH IMPEDANCES, WHICH WERE BETWEEN 870-1100 OHMS AND NO FALLS OR TRAUMAS WERE REPORTED. THE REPRESENTATIVE WAS GOING TO MEET WITH THE PATIENT AGAIN FOR REPROGRAMMING. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. ADDITIONAL INFORMATION RECEIVED FORM THE MANUFACTURER REPRESENTATIVE REPORTED THAT IMPEDANCES SHOW ELECTRODE 11 AT 10730 OHMS, ELECTRODE 15 AT 10540 OHMS AND ELECTRODES 12, 13 AND 14 AS GREATER THAN 40000 OHMS. THE PATIENT WAS PROGRAMMED USING ELECTRODES 2, 3, 4, 8, 9 AND 10 WITH PULSE WIDTH 450 AND 130 HZ. TESTING IMPEDANCES WITH REFERENCE ELECTRODE 2 SHOWED ELECTRODES 0-10 RANGE FROM 750 TO 3360 OHMS. WHEN USING REFERENCE 10 ELECTRODE 9 WAS 11000 OHMS AND ELECTRODE 11 WAS 15000 OHMS. THE PATIENT NEEDED STIMULATION DOWN THE LEG AND WHEN TRYING CONTACTS 8-15 THE PATIENT WAS FEELING STIMULATION IN HIS STOMACH BEFORE REACHING DOWN THE LEG. AN OUT OF RANGE MESSAGE WAS SEEN WITH ALL CONTACTS AND AN X-RAY SHOWED NO MOVEMENT AND NO FALLS OR TRAUMAS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WASN¿T DETERMINED. THE REP REPORTED THAT THE PATIENT DENIED FALLS OR SIMILAR SCENARIOS, ALTHOUGH IMPEDANCES AND INCREASED PAIN POINT TO OTHERWISE. THE REP REPORTED THAT THEY ATTEMPTED TO REPROGRAM AROUND THE ELECTRODES WITH IMPEDANCES. THE PATIENT WAS BEING SENT FOR AN X-RAY AND AN MRI. THE REP REPORTED THAT THEY WERE WAITING FOR THE MRI RESULTS TO PROCEED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391064 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR