BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3462365 · Received November 12, 2013

    Report

    Report Number
    3004209178-2013-20570
    Event Type
    Injury
    Date Received
    November 12, 2013
    Date of Event
    September 13, 2013
    Report Date
    October 23, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL # UNKNOWN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37602, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT # V094755, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V050681, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT POST IMPLANT. IT WAS ADDED THAT THE COMPANY REPRESENTATIVE HAD SET THE AMPLITUDE AT 2/3V. IT WAS REPORTED THAT PATIENT WAS HAVING ¿INTERNAL SHAKING; NO ONE COULD SEE IT AND FELT NAUSEATED.¿ IT WAS REPORTED THAT FOUR DAYS AFTER THE DAY OF THIS REPORT THE AMPLITUDE WAS CHANGED BACK TO OLD SETTING, 4.1/4.3V AND PATIENT FELT FINE FOR COUPLE OF HOURS. IT WAS INDICATED THAT PATIENT FELT FATIGUE AND HER VOICE FELT WEAK. IT WAS NOTED THAT PATIENT CONTINUED TO HAVE FREEZING AND STIFFNESS IN THE NECK. IT WAS ADDED THAT THERE WAS NO CHANGE IN MEDICATION AND ANESTHESIA INFORMED COULD BE DUE TO POST-SURGICAL. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT DID NOT HAVE ACCESS TO ADJUST STIMULATION. FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED RIGHT SIDE IMPEDANCES WERE HIGH WHEN THEY WERE CHECKED ON (B)(6) 2013. THE PATIENT WAS NOT GETTING EFFECTIVE STIMULATION. ALL IMPEDANCES USING CONTACT ZERO WERE GREATER THAN 22,000 OHMS. IT WAS NOTED THIS WAS THE PATIENT¿S THERAPEUTIC CONTACT. THEY ATTEMPTED TO REPROGRAM USING CONTACT ONE. PROGRAMMING WAS UNSUCCESSFUL TO THE PATIENT¿S SATISFACTION. THE PHYSICIAN EXPLORED THE STIMULATOR SITE ON (B)(6) 2013 AND FOUND A LOOSE CONNECTION. IMPEDANCE CHECK WAS NORMAL AND PATIENT RESUMED THERAPEUTIC SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582507 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention