BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4932065 · Received July 22, 2015

    Report

    Report Number
    3004209178-2015-13862
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V821660, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID; 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF STIMULATION. THE STIMULATION HAD BEEN TURNED OFF IN 4 DIFFERENT SITUATIONS. THE FIRST WAS IN (B)(6) 2014 DURING DINNER TIME WHEN THE PATIENT "FELT WEIRD". THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS CHECKED AND THE INSR CONFIRMED THE DEVICE HAD BATTERY LIFE BUT THE STIMULATOR WAS TURNED OFF. THE SECOND SITUATION WAS IN (B)(6) 2015 AND IT HAPPENED IN THE MIDDLE OF THE NIGHT. THEY HAD CONFIRMED THE STIMULATION HAD BEEN TURNED OFF BY THE RECHARGER. THE THIRD SITUATION WAS ON (B)(6) 2015. TOWARDS THE EVENING HOURS THE PATIENT DID NOT FEEL WELL, THEY HAD DIFFICULTY SWALLOWING AND SPEAKING. THEY CONFIRMED THE THERAPY WAS OFF BY THE PATIENT PROGRAMMER. THEY HAD PRESSED THE ORANGE CHECK BUTTON AND THEN PRESSED THE GRAY BUTTON TO TURN THE STIMULATION BACK ON. THE FOURTH SITUATION WAS THE DAY AFTER AND THEY FELT TINGLING ON THEIR FACE, COULD NOT SPEAK, AND HAD TROUBLE SWALLOWING. THE PATIENT'S HANDS AND FEET WERE CURLING AND IT WAS DIFFICULT TO CATCH HER BREATH. THEY HAD PLACED THE INSR ON THE PATIENT AT 2:28PM AND BY 4:20PM THEY CONFIRMED THE STIMULATION WAS TURNED OFF. THE BEGINNING BATTERY WAS 50% AND THEY WERE GETTING 6-8 COUPLING BARS. WHEN USING THE RECHARGER, THEY DID NOT GET THE ANTENNA LOCATE (AL) SCREEN. THE RECHARGER WOULD MAKE A LOT OF CLICKING SOUNDS EVERY 2 MINUTES BUT WOULD CONTINUE TO GET 6-8 COUPLING BARS. THE PATIENT WAS NOW CHARGING ABOUT 3 HOURS TO GET THE DEVICE FULL. WHEN THE DEVICE WAS AT 75% FULL IT WOULD BE DRAINED TO 25% BY THE NEXT MORNING. IT WAS NOTED IT WAS A GRADUAL CHANGE IN SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN THOUGHT THE BATTERY WAS GETTING RECHARGED SO FREQUENTLY THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DYING PREMATURELY. IMPEDANCE MEASUREMENTS WERE TAKEN AND THERE WERE NO ELECTRODES OUT OF RANGE. THE IMPLANT WAS ON AND THERE WERE NO EMI EXPOSURES. THE PATIENT EXPERIENCED SYMPTOMS WHEN THE INS WAS OFF BUT THEY WERE NOT RELATED TO POSITIONAL MOVEMENT. THE PATIENT HAD A SUDDEN RETURN OF SYMPTOMS. THE PATIENT HAD DYSTONIA. ALL OCCURRENCES WERE NOTED TO HAPPEN DURING OR AFTER RECHARGING. A LONGEVITY CALCULATION WAS PERFORMED WHICH SHOWED THE INS WOULD BE AT A LOW (25%) CHARGE AFTER 3.47 DAYS AND WOULD BE EMPTY (0%) AT 4.63 DAYS WITH THE PATIENT'S CURRENT SETTINGS. ADDITIONAL INFORMATION RECEIVED 4 DAYS LATER REPORTED THE ANALYSIS OF THE DATA FROM THE EXTERNAL CHARGING DEVICE WAS COMMUNICATED TO THE PHYSICIAN VERBALLY ON (B)(6) 2015. THE DESCRIBED DEVICE ISSUE HAD BEEN RESOLVED. THE CAUSE OF THE PROBLEM WAS THE PATIENT WASN'T CHARGING THE DEVICE PROPERLY. THE PATIENT WOULD LET THE DEVICE GO TO 0% CHARGE. THE PHYSICIAN PLANNED TO MEET WITH THE PATIENT'S FAMILY AND DISCUSS THEIR OPTIONS. THE DEVICE WAS PROVEN THROUGH DATA ANALYSIS TO BE WORKING PROPERLY BUT THE PATIENT WAS NOT CHARGING APPROPRIATELY. PLEASE SEE MANUFACTURER REPORT #3004209178-2015-13860 FOR INFORMATION ON THE PATIENT'S CONCOMITANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477298 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR