BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5530010 · Received March 28, 2016

    Report

    Report Number
    3004209178-2016-05508
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    February 27, 2016
    Report Date
    March 28, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED THAT TWO HOURS AFTER THE PATIENT TOOK THEIR 10 AM DOSE OF RYTARY ON SATURDAY, PATIENT EXPERIENCED PAINFUL RIGIDITY. THEY FELT AS IF THEIR LEGS WERE TURNING IN ON THEM. THEY HAD DIFFICULTY MOVING AND WERE UNABLE TO MOVE. THEIR DYSKINESIA HAD WORSENED. IT WAS INDICATED THAT THE PATIENT HAD INCREASE VOLTAGE ON THE RIGHT SIDE IMPLANTABLE NEUROSTIMULATOR(INS) AT SOME POINT AND WHEN THE PATIENT WAS SEEN IN THE ER, THE HCP DECREASED THE VOLTAGE BACK TO PREVIOUS LEVEL AND PATIENTSYMPTOM IMPROVED. HCP BELIEVED THE PATIENT HAD A "PEAK DOSE DYSTONIA" WHICH IMPROVED AFTER CHANGING THE SETTINGS BUT STILL CONCERNED THAT DYSKINESIA HAD GOTTEN WORSE AND PATIENT WAS EXPERIENCING SOME "WEARING OFF" (IN REFERENCE TO MEDICATION). HCP SPECULATED THAT PATIENT'S SYMPTOMS MIGHT HAVE WORSENED WHEN PATIENT INCREASED VOLTAGE ON RIGHT SIDE. IT WAS INDICATED THAT THE PATIENT STARTED SEEING OUT OF REGULATION MESSAGE (OOR) ON SATURDAY ON THE LEFT SIDE WHEN CHECKING THE DEVICE AND HAS CONTINUED TO SEE IT SINCE THEN. THE PATIENT NEVER EXPERIENCED ANY SHOCKING. THE THERAPY SETTINGS AND ELECTRODE IMPEDANCE TAKEN ON THE DAY OF REPORT AND READ AS FOLLOW: RIGHT SIDE, 0- 1+, 3.0V, 60 PW, 180 RATE C0 2724, C1 572, C2 563, C3 2562, 01 2277, 02 2284, 03 4364, 12, 37, 13 ,1950, 23, 1940. LEFT SIDE: 0- 1+, 3.4V, 90 PW, 180 RATE C0 2985 C1 1166, C2 1326, C3 1642, 01 2251, 02 3344, 03 4015, 12 1386, 13 2076, 23, 1030. IT WAS ALSO REPORTED THAT THEY TESTED THE IMPEDANCES ON MONDAY WHEN PATIENT WAS SEEN IN ER AND EVERYTHING ON THE LEFT SIDE WAS NORMAL. THE PATIENT HAD NOT HIT THEIR HEAD OR CHEST RECENTLY. THE PATIENT APPEARED TO BE GETTING BENEFIT FROM THE INS FOR THEIR DYSTONIA BUT WAS STILL EXPERIENCING SOME"WEARING OFF". THE X-RAYS WERE BEING PERFORMED WHILE ON THE CALL. NO OUTCOME OR INTERVENTIONS 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. THE INDICATIONS FOR USE FOR THIS PATIENT WERE PARKINSON'S DUAL AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184320 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR