BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3122856 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08005
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    May 2, 2013
    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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0519173V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0519173V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THAT AN OUT OF REGULATION (OOR) CONDITION WAS EXPERIENCED STARTING ON (B)(6) 2013 ON THE LEFT SIDE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT GOT A QUESTION MARK WHEN HE TRIED TO CHECK THE DEVICE THROUGH HIS CLOTHING, BUT WAS ABLE TO COMMUNICATE WHEN CHECKED ON THE SKIN. THE PATIENT STATED THEY FELL ABOUT ONCE A DAY. IT WAS FURTHER NOTED THAT THE PATIENT WAS RECEIVING ELECTRIC SHOCKS FOR ABOUT TWO WEEKS PRIOR TO THE REPORT. PATIENT STATED ¿THEY HAD TO HAVE X-RAY¿S TAKEN TO SEE IF THERE¿S ANY BREAK IN THE WIRE.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE THERAPY IMPEDANCE WAS LOWER THAN EXPECTED. THE IMPEDANCES ON CONTACTS 0, 1, AND 3 WERE EXTREMELY LOW (IN THE DOUBLE DIGITS); THE IMPEDANCES INDICATED A SHORT IN THE SYSTEM. FOR THE PAST 2 MONTHS, EVERY TIME THE PATIENT TURNED HIS HEAD TO THE RIGHT, HE FELT A SHOCKING ON THE LEFT SIDE OF HIS BODY DOWN HIS ARM. THE PATIENT¿S THERAPY WAS NOT GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224544 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR