BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6102657 · Received November 15, 2016

    Report

    Report Number
    3004209178-2016-24001
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 25, 2016
    Report Date
    February 20, 2019
    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 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.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS OF NORMAL WEIGHT AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THE POR WAS PARITY POR, AND THE DATE ON THE INS WAS NOT CORRECT DUE TO THIS ISSUE. THE DATE WAS CHANGED SUCCESSFULLY.

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT A POWER ON RESET (POR) OCCURRED ON (B)(6), AND THE PATIENT HAD DYSTONIC SYMPTOMS AS A RESULT. IT WAS STATED THAT THE PATIENT IS GOING TO THE ER TO CLEAR THE POR. THE PATIENT IS FEELING SENSATIONS ON THE LEFT CORNER OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS), "LIKE SPARKLING WATER." THEIR THERAPY CAN'T BE TURNED ON MORE THAN 3.2 V AS WELL, AND THEIR PREVIOUS AMPLITUDE WAS 4.5 V. ELECTRODE IMPEDANCES WERE TAKEN AND FOUND TO BE BETWEEN 798-1276 OHMS, WITH ELECTRODE SETTINGS C+, 3-, 2-, 1-, 0, 4.5V AMPS, 180US, 170HZ RATE. ADDITIONAL INFORMATION RECEIVED FROM THE REP ON (B)(6) REPORTED THAT A REVISION/EXPLANT DATE IS NOT YET DECIDED, AND THAT THE PATIENT HAS NOT HAD THERAPY DURING "1,5" DAY BECAUSE OF THE POR. THE PATIENT CAN'T RECEIVE THE RIGHT AMPLITUDE WITHOUT SIDE EFFECTS TURNING UP AT THE RIGHT SIDE OF THE BODY. INSTEAD OF 4.5 , "IT'S JUST POSSIBLE TO START UP AT 3.5V." THE PATIENT WAS GIVEN THE ABILITY TO ADJUST THE RANGE OF AMPLITUDE AT HOME, AND THE DEVICE IS STILL IMPLANTED AND REMAINS IN SERVICE. ON (B)(6) IT WAS REPORTED THAT DURING THE 7 DAYS PRIOR TO ADDITIONAL INFORMATION THE PATIENT'S AMPLITUDE HAS INCREASED FROM 3.5 V TO 3.9 V. THE PATIENT WILL ATTEMPT TO ADJUST FURTHER ON TO 4.5 V, BUT THEY WILL HAVE TO DO IT IN SMALLER STEPS BECAUSE OF THE SIDE EFFECTS ON THE RIGHT SIDE OF THEIR BODY. IT WAS NOTED THAT THE PATIENT HAS DYSTONIA ON THE RIGHT SIDE OF THE BODY AND PARKINSON'S DISEASE, BUT THE DBS IS IMPLANTED FOR THE TREATMENT OF DYSTONIA. THE PATIENT'S INDICATION FOR IMPLANT IS DYSTONIA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT ONLY ONE INFORMATION POWER ON RESET (POR) WAS DISPLAYED. THE MANUFACTURER REPRESENTATIVE HAD INITIALLY REPORTED FOUR PORS, BUT THERE WAS ONLY ONE POR SEEN MULTIPLE TIMES. THE POR WAS SEEN ON THE PATIENT PROGRAMMER AND RECHARGER ON (B)(6) 2016. THE SAME POR SHOWED UP ON TWO DAYS WHEN THE PATIENT WAS TRYING TO READ THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD CHANGED THE BATTERIES IN THE PATIENT PROGRAMMER TO MAKE SURE THE PROGRAMMER DID NOT LACK ENERGY. THE CAUSE OF THE POR WAS DETERMINED, BUT THE CAUSE OF THE SENSATIONS FROM THE INS WAS NOT. THE PATIENT WAS NOT NEAR ANY SOURCES OF ELECTROMAGNETIC INTERFERENCE (EMI) AND THEY WERE USUALLY AT HOME WHEN THEY CHECKED OR CHARGED THE INS. THE PATIENT'S HEALTH CARE PROVIDER (HCP) DID TROUBLESHOOTING. THE MANIPULATED THE LEADS, EXTENSION, AND INS POCKET. THE PATIENT FELT THE PAINFUL SENSATION AT THE UPPER LEFT CORNER WHERE THE EXTENSIONS GO INTO THE INS IN THE POCKET. THE PATIENT DID NOT FEEL ANY SENSATION ON THE LEAD OR EXTENSION. IMPEDANCES WERE TESTED AGAIN, BUT THEY WERE VERY SIMILAR TO MEASUREMENTS AS BEFORE. THE HCP HAD INSTRUCTED THE PATIENT TO SLOWLY TRY INCREASING STIMULATION OVER TIME FROM 3.5 TO 4.5V. THE PATIENT HAD INCREASED STIMULATION SET BY STEP UP TO 4.2V, BUT FELT THE SENSATION A LOT. THE PATIENT DECIDED TO STOP AT 4.0V AND THEY WERE OKAY WITH 4.0 AT THE MOMENT. THE PATIENT WAS RECEIVING THERAPY, BUT IT WAS NOT AS GOOD AS BEFORE. A FOLLOW UP APPOINTMENT WAS PLANNED FOR NEXT YEAR OR SOONER IF ANYTHING CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754522 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR