BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3832746 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09614
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 6, 2014
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# VA02Y9T, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0444061V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD GONE IN APPROXIMATELY 2 WEEKS PRIOR TO THE DATE OF THIS REPORT WITH PAIN AROUND THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT IT WAS TENDER TO TOUCH. A COMPUTED TOMOGRAPHY (CT) AND ULTRASOUND WERE PERFORMED AND THERE WAS NO FLUID AROUND THE DEEP BRAIN STIMULATOR. THE PATIENT¿S WORK UP FOR INFECTION WAS NEGATIVE. IT WAS FURTHER NOTED THAT THE DEEP BRAIN STIMULATOR WAS SHUT OFF. THE PATIENT HAD A FOLLOW UP ON (B)(6) 2014 AND HAD NO PAIN BUT WANTED HER REPORT RUN BY OTHERS. ALL IMPEDANCES WERE OUT OF RANGE BUT NOTHING WAS SHOWING A BLATANT OPEN. ALL IMPEDANCES WERE ELEVATED FROM TYPICAL NORMAL RANGE. IT WAS NOTED THAT HISTORICAL IMPEDANCES COULD POSSIBLY PROVIDE INFORMATION ON WHEN THE CHANGE HAD OCCURRED AND THAT PERHAPS THE IMPEDANCES PRECEDED THE PAIN. IT WAS NOTED THAT THEY DID NOT THINK IMPEDANCES WOULD CAUSE PAIN. ADDITIONAL INFORMATION RECEIVED REPORTED NO MALFUNCTIONS WERE SEEN OR CAUSE DETERMINED. THE PATIENT OUTCOME WAS THAT THE PATIENT REPORTED NO PAIN AND THE BATTERY WAS TURNED BACK ON BUT WAS AT A LOWER VOLTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310488 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR