BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8270193 · Received January 23, 2019

    Report

    Report Number
    3004209178-2019-01504
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 27, 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.

    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 A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE INS WAS REPROGRAMMED TO USE LESS ENERGY AND "EVERYTHING WAS FINE." NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER AND MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT SAW A SETTINGS NOT AVAILABLE MESSAGE ON THE CONTROLLER SINCE (B)(6) 2019. THE PATIENT CAN'T INCREASE STIMULATION. THE PATIENT SAID THAT THE DEVICE WAS REPROGRAMMED ON (B)(6) 2019. THE PATIENT WENT 48 HOURS INCREASING AND DECREASING STIM WITH NO ERROR MESSAGES. THE PATIENT SAID SHE SET STIM LOWER THAN SHE DID WHEN SHE LEFT THE OFFICE ON (B)(6) 2019. THE PATIENT HASN'T HAD ANY FALLS OR TRAUMA. THE PATIENT CHANGED FROM GROUP B TO GROUP A AND WAS STILL SEEING THE SETTINGS NOT AVAILABLE MESSAGE. THE PATIENT SAID THE IMPLANT IS CHARGED. THE PATIENT MENTIONED SHE IS SUPPOSED TO CHARGE HER IMPLANT EVERY 1.4 DAYS, BUT THE BATTERY IS ONLY LASTING 18 HOURS. THE PATIENT CHARGED THE INS TWO TIMES ON (B)(6) 2019. A REP CALLED IN LATER ON (B)(6) 2019. THE REP SAID THE PATIENT WAS PROVIDED 2 HD PROGRAMS FOLLOWING IMPLANT. THE PATIENT WAS DOING FINE, BUT THEN STARTED TO SEE THE SETTINGS NOT AVAILABLE MESSAGE, COULD ONLY GO DOWN IN SETTINGS, AND NEEDED TO CHARGE ALL THE TIME. THE PATIENT'S STIM WAS FEELING "CHOPPY" ON (B)(6) 2019 AT 8.5 MA, 90 PW, 1000 HZ. A REPORT SHOWED THE PATIENT WAS CHARGING EVERY 1.4 DAYS, BUT AFTER A FEW DAYS SHE WAS CHARGING MULTIPLE TIMES A DAY. THE REP STATED ONCE THE PATIENT WAS PROGRAMMED TO 200 PW THE COVERAGE AREA WAS TOO BROAD AND CAPTURED MORE AREA THAN NEEDED. THEY ARE TRYING TO CAPTURE RIGHT FOOT/ANKLE AND SOME LEG. THE REP BROUGHT PW BACK TO 180PW, 1000 HZ AND 10.0MA AND WAS NOT SEEING OOR ON THE TABLET. THE REP LOOKED AT IMPEDANCES AND PROVIDED THE FOLLOWING: CONTACT 6: 680, 11-1460, 8-590,11-600, 12-600, 14-660, 15-750. THE OOR WAS NO LONGER PRESENT AND TROUBLESHOOTING RESOLVE THE REPORTED ISSUE. THE REP WAS GOING TO CONTINUE TO FINE TUNE THE SETTINGS. ENERGY CONSUMPTION SHOWED THE RECHARGE INTERVAL WILL BE 0.7 DAYS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64674 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR