BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3011544 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03940
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    March 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A 'PRETTY HARD FALL' IN (B)(6) BUT THERE WAS NO TRAUMA TO THE HEAD. ABOUT A MONTH LATER, THE PATIENT STARTED GETTING SHOCKING SENSATIONS ALL OVER HIS BODY, SPECIFICALLY IN THE PATIENT'S NECK, LEG AND THE RIGHT SIDE OF HIS BODY. THE REPORTER INDICATED THAT THIS COULD HAVE HAPPENED AS MANY AS 50 TIMES A DAY; IT WAS HAPPENING CONSTANTLY AND IT WASN'T POSITIONAL. THE PATIENT TURNED HIS DEVICE OFF AS IT WASN'T HELPING HIM EVEN WHEN IT WASN'T SHOCKING HIM. THE PATIENT SAW A NEUROLOGIST A WEEK PRIOR TO THE REPORT, WHO TURNED THE VOLTAGE DOWN FROM 5.4V TO 1.3V AND PROGRAMMED THE PATIENT TO THE ELECTRODE COMBINATION C+,2-,3-. IN DOING SO, THE SHOCKING WENT AWAY BUT THE PATIENT HAD NO THERAPEUTIC BENEFIT WHATSOEVER. THE PATIENT WAS SEEN ON THE DAY OF THE REPORT AND WHEN THE PATIENT'S STIMULATION WAS INCREASED PAST 1.5V, THE PATIENT GOT SIDE EFFECTS (FACIAL PULLING, HIGH DEVIATION AND CONSTANT PARASTHESIA) THAT DID NOT GO AWAY. WHEN STIMULATION WAS TITRATED UP TO 3.3V THE PATIENT'S SPEECH BECAME SLURRED. ALL UNILATERAL IMPEDANCE MEASUREMENTS WERE 'HIGH.' BILATERAL IMPEDANCES WERE BETWEEN 5,000 OHMS AND 11,000 OHMS. THE ELECTRODE COMBINATION THE PATIENT WAS PROGRAMMED TO HOWEVER WORKED. THROUGH 'INVESTIGATIVE WORK,' IT WAS DISCOVERED THAT 'THE LEAD WASN'T ANYWHERE NEAR WHERE IT SHOULD HAVE BEEN TO BEGIN WITH.' AS SUCH, THE PATIENT HAD NEVER HAD GOOD SYSTEM CONTROL AND SOME ELECTRODE COMBINATIONS GAVE THE PATIENT SIDE EFFECTS SUCH AS FACIAL PULLING, EYE DEVIATION AND SLURRED SPEECH. FOLLOW-UP INFORMATION RECEIVED INDICATED THAT IMPEDANCE VALUES WERE WITHIN RANGE AND NOTHING COULD SYSTEMATICALLY BE DETERMINED AS A CAUSE. IT WAS NOTED THAT LEAD PLACEMENT WAS VERY POOR WHICH CAUSED COMPLICATIONS IN PROGRAMMING AND THERAPY EFFICACY. X-RAYS WERE TAKEN AND RESULTS WERE PENDING. THE REPORTER INDICATED THAT THE PATIENT WAS ULTIMATELY GOING TO BE ADVISED ON A LEAD REVISION FOR BEST THERAPY OUTCOME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN REFERRED TO A NEUROSURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEVER FOLLOWED UP TO MAKE AN APPOINTMENT TO HAVE A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113930 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1