BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7112637 · Received December 13, 2017

    Report

    Report Number
    3004209178-2017-25897
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 30, 2017
    Report Date
    October 10, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF CONCOMITANT PRODUCT: PRODUCT ID 37601, LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED:. PRODUCT TYPE IMPLANTABLE NEUROSTIM ULATOR. DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP AND THE CONSUMER VIA THE REP. IT WAS REPORTED THERE WAS AN OUT OF REGULATION (OOR) MESSAGE ON THE TABLET AND PATIENT PROGRAMMER. PROGRAMMING AND IMPEDANCES VALUES WERE: LEFT STN C2, 0.3 VOLTS, 90USEC, 185HZ, 1343 OHMS. C0: 1189 OHMS; C1: 1369; C2: 1359; C3: 1059 01 1431 02 1909 03 1845 21 1555 31 1827 23 1453 OHMS; RIGHT STN C10: 2.1 VOLTS, 90PW, 185HZ, 1024 OHMS; C8: 1735 OHMS; C9: 1316; C10: 1039; C11: 2539 89 1651 810 1998 811 3577 910 1369 911 2889 1011 1889 OHMS. IT WAS REPORTED THE REP DID IMPEDANCE TESTING IN VARIOUS HEAD POSITIONS BUTTHE IMPEDANCE VALUES WERE SIMILAR. TECH SERVICES TOLD THE CALLER THERE WAS A SHORT IN THE SYSTEM THAT WAS NOT DETECTABLE. IT WAS NOTED THE PATIENT'S DEVICE PARAMETER WAS NOT LIKELY THE CAUSE OF THE OOR. THE PATIENT'S INS BATTERY WAS AT 2.87 V. THE PATIENT STARTED TO GET THE OOR MESSAGE NOVEMBER 2017 BUT THE PATIENT HAD BEEN ABLE TO CLEAR THE MESSAGE UNTIL FEB/MARCH 2018. THE PATIENT RAN STIMULATION AT 0.3 V DUE TO HYPOPHONIA ISSUES. THERE HAD BEEN NO REPORTS OF ACCIDENTS OR FALLS/TRAUMA. THE PATIENT'S WIFE STATED THE PATIENT TURNED THERAPY OFF WHEN HE SLEPT. THE PATIENT DID NOT HAVE ANY THERAPY ISSUES OR SYMPTOMS TO REPORT. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED. THE CALLER CALLED BACK AND IT WAS REPORTED THE MANAGING CLINICIAN HAD CALLED TECH SERVICES ABOUT THIS SAME ISSUE IN THE PAST. THE PATIENT'S WIFE REPORTED THE SAME MESSAGE HAD APPEARED EVERY TIME SHE HAD CHECKED IT SINCE THE PROBLEM BEGAN. ON THE DAY OF THE REPORT THE PATIENT WAS PROGRAMMED AT 0.8V/90/185 AND THE THERAPY IMPEDANCE MEASURED ABOUT 1,300OHMS. THE PATIENT PROGRAMMER BEHAVED NORMALLY AT THIS SETTING. THE PATIENT AND HIS WIFE WERE SATISFIED WITH THIS AND UNDERSTOOD THE ROOT CAUSE OF THE ISSUE WAS STILL UNKNOWN. THEY AGREED TO REPORT ANY SYMPTOMS RELATED TO STIMULATION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37601, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE PATIENT HAS HAD TO DO A TON OF EXPERIMENTING. THE PATIENT'S STN STIMULATOR, WHICH USED TO BE ON 4 AND 4 WAS NOW ON 2 AND .3 AND THEIR MOVEMENT DISORDER WAS BEING CONTROLLED REALLY WELL WITH THE GPI STIMULATION WHICH IS AT 3.9 AND 3.9. THE HCP INITIALLY SET THE GPI ONE AT 3 AND 3 BUT OVER MANY WEEKS OF EXPERIMENTATION THEY'VE INCREASED IT. THE CALLER SAID "WHAT THEY'VE BEEN TOLD WAS THAT THEIR REMOTE HAS BEEN DESIGNED TO NOT WORK BECAUSE PEOPLE WHO HAVE OCD KEEP USING IT". THE CALLER WASN'T INDICATING THAT THEY HAVE OCD. THE PATIENT WAS JUST TRYING TO EXPERIMENT TO GET THEIR STN DOWN AS LOW AS POSSIBLE AND THEIR GPI ONE UP TO THE POINT WHERE THEIR MOVEMENT DISORDER WAS CONTROLLED AND THEY COULD SPEAK AND THEY HAVEN'T HIT THE "SWEET SPOT" YET. THE CALLER WENT ON TO SAY THAT IT TAKES DAYS IN BETWEEN SOMETIMES FOR THEM TO KNOW HOW SOMETHING WAS AFFECTING THEM. THE PROBLEM THEY WERE CALLING ABOUT WAS FROM A WEEK AGO, THEY TURNED THEIR STN DOWN FROM 2 TO 1.5 AND THE PATIENT SEEMED TO BE ABLE TO TALK BETTER BUT THEY WERE TREMORING MORE SO THEY WANTED TO TURN IT UP BUT IT WOULDN'T LET THEM TURN IT UP. OOR WAS SEEN ON THE PATIENT PROGRAMMER. THE DOCTOR CHECKED IMPEDANCES AND FOUND NO ISSUE. THE CALLER LEARNED FROM MEDTRONIC THAT THEY HAVE TO OVERRIDE THE MESSAGE BY PRESSING ONE OF THE ARROWS AND THEY CAN INCREASE/DECREASE AS NEEDED, BUT LAST WEEK THEY WERE NOT ABLE TO INCREASE AFTER DECREASING IT DOWN TO 1.5. THE CALLER SAID IT KEPT GIVING THEM THE OOR MESSAGE UNTIL JUST TODAY THEY WERE ABLE TO INCREASE IT AGAIN. THE OOR WAS SEEN WHEN THEY WERE ADJUSTING SETTINGS. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT WAS REPROGRAMMED ON FRIDAY AND THE ONE PROGRAM WAS LEFT AT 0.0 V. THE PATIENT ATTEMPTED TO ADJUST THE THERAPY UP TO .3V AND ENCOUNTERED THE OOR SCREEN. THE PATIENT WAS GETTING THERAPY AND WAS THERAPEUTICALLY DOING WELL. THE CALLER READ THE DEVICE WITH THE 8840 AND ENCOUNTERED AN OOR. THEY REMOVED AN ELECTRODE AND DECREASED THE SETTINGS AS THE SCREEN ADVISED THEM TO DO. THE HIGHEST IMPEDANCE VALUE WAS 2453 OHMS ON C11, BUT THAT WAS NOT NEW. IT HAD BEEN THAT IN THE PAST. THE LOWEST VALUES ARE ON THE 900S. THE PATIENT WAS PROGRAMMED IN CONSTANT VOLTAGE MODE C<(>&<)>2 2V, 90PW 185 RATE, C <(>&<)>10 .3 V 90 185. THERAPY IMPEDANCES WERE 954 AND 980. THE CALLER WAS ADVISED TO TAKE IMPEDANCES WHEN THE PATIENT WAS IN A DIFFERENT POSITION, AND THEY WERE ALL THE SAME. THE CALLER STATED THAT THE PATIENT HAD AN ISSUE IN THE PAST WITH A DAMAGED WIRE THAT HAD TO BE REPLACED, SO THEY KNEW WHAT THAT FELT LIKE AND THEY WERE NOT FEELING THAT WAY NOW. THE BATTERY VOLTAGE WAS 2.92. THE CALLER WAS ABLE TO REPLICATE THAT IN THE OFFICE BY USING THE PATIENT PROGRAMMER TO INTERROGATE OVER AND OVER. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THE PATIENT GOT A SECOND SYSTEM IMPLANTED ON (B)(6) 2017. THE WHOLE POINT OF THE SECOND STIMULATOR WAS TO TURN DOWN THE STN SETTINGS AND TURN UP THE GPI SETTINGS AND BALANCE IT SO THEY COULD SPEAK BUT THEIR MOVEMENT WAS CONTROLLED. THE DOCTOR PROGRAMMED IT ON (B)(6) 2017 AND LEFT THEM A LOT OF ROOM TO EXPERIMENT WITH ADJUSTMENTS BECAUSE THE PATIENT WAS RE-LEARNING TO SPEAK. THE PATIENT WAS INCREASED ON THE STN SIDE FROM ZERO TO 0.3 AROUND (B)(6) 2017 BECAUSE THE PATIENT WAS HAVING TROUBLE SLEEPING AT NIGHT BECAUSE THEY WERE SHAKING TOO MUCH AND THEY HADN'T BEEN ABLE TO ADJUST IT SINCE THEN. THE GPI SIDE WAS WORKING FINE. ON THE STN SIDE, THE CALLER WAS GETTING AN OOR MESSAGE. THE CALLER SAW AN OOR WHEN TRYING TO INCREASE PAST 0.3, TROUBLESHOOTING WAS PERFORMED. IT WAS RECOMMENDED TO WORK WITH THE HEALTHCARE PROVIDER (HCP) IF THE OOR CONTINUES. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893388 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR