BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5055871 · Received September 4, 2015

    Report

    Report Number
    3004209178-2015-17314
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    September 1, 2014
    Report Date
    May 23, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V972376, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V972376, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATES THAT INFORMATION FROM MANUFACTURER¿S REPORT #3004209178-2017-08686 WAS ALREADY REPORTED IN THIS REPORT ( #3004209178-2015-17314). ANY ADDITIONAL INFORMATION REGARDING THAT EVENT WILL BE SUBMITTED AS A SUPPLEMENTAL SUBMISSION TO THIS REPORT. 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 · 1

    A CONSUMER REPORTED THEY HAD A LOSS OF THERAPY AND A LOSS OF STIMULATION. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) SHUT OFF BY ITSELF IN (B)(6) 2014 AND WAS OFF UNTIL (B)(6) 2015. IN (B)(6) 2014, THE PATIENT BEGAN HAVING PROBLEMS WITH WALKING AND THEY HAD GOTTEN TO THE POINT WHERE THEY COULD NOT WALK AT ALL. THE PATIENT WENT TO SEE THEIR HEALTH CARE PROVIDER (HCP) EVERY MONTH AND THE HCP NEVER REALIZED THE THERAPY WAS OFF EVEN THOUGH THEY WERE REPORTING THAT SOMETHING WAS WRONG. ANOTHER HCP TOLD THE PATIENT THAT THE INS WAS OFF SO THEY TURNED THE THERAPY BACK ON. THE PATIENT FELT INSTANT RELIEF ONCE THE INS WAS TURNED BACK ON. THE PATIENT PLANNED TO CONTACT THEIR HCP FOR PROGRAMMING. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR PARKINSONS DUAL AND MOVEMENT DISORDERS REPORTED APPROXIMATELY TWO YEARS AGO THEY HAD AN ISSUE WITH THEIR DEEP BRAIN STIMULATOR (DBS) IMPLANT. THE CONSUMER WAS IMPLANTED ON (B)(6) 2012 BUT WAS LATER INFORMED THEIR DBS HAD BEEN TURNED OFF AND THAT IT WAS TURNED ON JUST PRIOR TO THEIR APPOINTMENT. ACCORDING TO THE CONSUMER IT WAS ¿THE EXACT DAY I HAD AN APPOINTMENT WITH THE HEALTHCARE PROVIDER (HCP).¿ IT WAS VERY DISTURBING TO THE CONSUMER THAT THEY KEPT TELLING THE HCP THAT THEY DIDN¿T FEEL GOOD AND THE HCP KEPT ADJUSTING THE DBS WHEN THEY FOUND OUT IT WASN¿T EVEN ON, AND THE CONSUMER HAD NO IDEA HOW IT GOT TURNED OFF. HOWEVER, ACCORDING TO THE STUDY THE CONSUMER WAS IN THEY SAID IT WAS OFF AS FAR BACK AS THEIR PATIENT PROGRAMMER (PP) COULD GO BACK SO THE CONSUMER HAD NO IDEA HOW A DOCTOR COULD PROGRAM THE DBS WHILE IT WAS IN THE OFF POSITION AND NOT EVEN KNOW IT. ACCORDING TO THE DOCTOR¿S AT THE STUDY THEY SAID THE CONSUMER WOULD NOT GET THE FULL BENEFIT FROM THE IMPLANTS BECAUSE IT WAS SHUT OFF FOR ALMOST A YEAR; THE CONSUMER REMEMBERED THEY DIDN¿T FEEL GOOD SO MUCH THAT THEY GOT VERY DEPRESSED, AND THEY STILL WEREN¿T FEELING THAT WELL, COULDN¿T TALK THAT CLEARLY ANYMORE, AND COULDN¿T WRITE. THE CONSUMER WAS UNSURE IF IT HAD ANYTHING TO DO WITH THE PP BECAUSE THE STUDY GAVE THEM A NEW PP, WHILE THE HCP¿S COMPANY CLAIMED THEY DIDN¿T SHUT IT OFF. THE CONSUMER ADDITIONALLY REPORTED THEY WONDERED HOW A HCP COULD REPROGRAM THE DBS WHEN IT WAS IN THE OFF POSITION, EVEN THOUGH THEIR PP DIDN¿T RELAY THAT MESSAGE TO THEM. DURING IMPLANT THE CONSUMER UNDERWENT 8 HOURS OF SURGERY AND IT SEEMED TO THEM THAT IF THEIR PP WASN¿T WORKING CORRECTLY THEY SHOULD HAVE BEEN AWARE OF THAT ALONG WITH THE DOCTOR. THE CONSUMER WAS LOOKING TO MAKE SURE THE DOCTOR OR MANUFACTURER¿S REPRESENTATIVE (REP) HAD THE ABILITY TO PROGRAM A PERSON THAT HAD THE DBS, OR MAYBE IT WAS THE PP THE CONSUMER HAD THAT WAS DEFECTIVE WHICH WAS WHY THEY GOT A NEW ONE. THE PATIENT¿S INS WAS REPORTEDLY TURNED BACK ON (B)(6) 2015 ABOUT A WEEK PRIOR TO A VISIT AT A PHYSICIAN¿S OFFICE ON (B)(6) , 2015. THE PATIENT¿S BALANCE ISSUES AND DYSARTHRIA WERE REPORTEDLY WORSE AT THIS VISIT, WHICH WAS APPARENTLY A RESULT OF THE DEEP BRAIN STIMULATION (DBS) NOT BEING ON SINCE AT LEAST (B)(6) 2014. THE PATIENT WAS PUT BACK ON SETTINGS SIMILAR TO WHAT THEY HAD PREVIOUSLY BEEN ON, BUT THERE WAS AN INCREASE IN AMPLITUDE FROM 2.3 TO 2.5 V ON THE LEFT AND THE RIGHT SIDE WAS UNCHANGED. THE PATIENT¿S RIGHT FOOT WAS FREEZING WHEN WALKING AND THE PATIENT WANTED TO MAKE SURE DBS WAS WORKING PROPERLY. THERE WAS NO CHANGE IN THE PATIENT¿S MENTAL STATUS. THE PATIENT WAS EVALUATED FOR SPEECH AND GAIT DIFFICULTY. THERE WAS A FALL A FEW MONTHS PRIOR TO THIS VISIT AND THEY WONDERED IF THE WORSENING SPEECH AND GAIT DIFFICULTY WERE RELATED TO THAT; HOWEVER, WORSENING OF SYMPTOMS WAS NOTED PRIOR TO FALL. PATIENT HAD INVOLUNTARY DYSTONIC MOVEMENT OCCURRING IN THE RIGHT LOWER EXTREMITY, IMPEDING THEIR GAIT. THE PATIENT HAD MODERATE BRADYKINESIA AND FREEZING WHEN TURNING AT THE END OF THE HALL. THEIR ELECTRODE IMPEDANCES WERE NORMAL. THE PATIENT HAD ANOTHER VISIT ON (B)(6) 2015. THE PATIENT FELT UNWELL AND APPEARED TO BE MORE ¿OFF¿ OVERALL. THE PATIENT¿S PHYSICIAN RECOMMENDED A SLIGHT INCREASE IN THE TOTAL SINEMET DOSE. THE PATIENT HAD A WORSENING OF SYMPTOMS: FREEZING, INTERMITTENT RIGHT LOWER EXTREMITY DYSTONIA AND DYSARTHRIC SPEECH. IT WAS NOTED THE PATIENT PREVIOUSLY HAD SOME BENEFIT IN FREEZING ON GROUPS B AND C, BUT THAT EFFECT APPEARED TO HAVE CEASED. THE PATIENT WAS PLACED BACK ON GROUP A WITH AN INCREASE IN VOLTAGE BILATERALLY (1.3 V ON LEFT AND 1.8 V ON RIGHT) IN AN ATTEMPT TO HELP WITH SOME MILD RIGIDITY. THE PATIENT WAS INSTRUCTED TO STAY ON GROUP A FOR AT LEAST A WEEK UNTIL FOLLOWING UP WITH ANOTHER HEALTHCARE PROFESSIONAL (HCP). THE PATIENT WAS DIRECTED TO START PHYSICAL THERAPY AGAIN FOR BALANCE AND GAIT DIFFICULTY. IT WAS NOTED THAT THE PATIENT HAD A TENDENCY TO DRAG THEIR RIGHT LEG WHICH HAS BEEN IMPEDING THEIR GAIT. THE PATIENT HAD BEEN USING A WALKER MOST OF THE TIME TO MOVE AROUND. THE PATIENT WAS ABLE TO SLEEP 7 TO 8 HOURS EACH NIGHT, BUT EXPRESSED ANXIETY AND INCREASED RATE OF HAIR FALLING OUT. PSYCHIATRIC EVALUATION AND CONSULTATION WAS RECOMMENDED FOR THE PATIENT¿S ANXIETY. THE PATIENT WAS SEEING A PSYCHIATRIST WHO PRESCRIBED ESCITALOPRAM. AN APPOINTMENT WITH AN ENDOCRINOLOGIST WAS RECOMMENDED TO ADDRESS THE THINNING HAIR. THE PATIENT HAD A POSITIVE ANTINUCLEAR ANTIBODY (ANA), NORMAL THYROID-STIMULATING HORMONE (TSH) AND MINIMAL ALTERATION IN T4. IT WAS R EPORTED THE PATIENT HAD SOME SYMPTOMS SUGGESTIVE OF HYPOTHYROIDISM, BUT THEIR TSH WAS NORMAL AT THE TIME. THE PATIENT WAS ON SINEMET 25/100, MODAFINIL 200 MG, ESCITALOPRAM 50 MG AND CLONAZEPAM 0.5MG AS OF (B)(6) 2015. THE PATIENT WAS EVALUATED IN THEIR ¿ON¿ STATE AP PROXIMATELY 2 HOURS AFTER SINEMET DOSE. THE PATIENT HAD DYSARTHRIC SPEECH WITH A SEQUENCE EFFECT, MILDLY INCREASED TONE WITH REINFORCEMENT BILATERAL UPPER EXTREMITY AND NORMAL IN BILATERAL LOWER EXTREMITY. THE PATIENT WAS ABLE TO TAKE SEVERAL STEPS FROM DOORWAY OF ROOM TO CHAIR. THE PATIENT¿S IMPEDANCES WERE AGAIN NORMAL AT THIS VISIT. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589305 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR