BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3770183 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08057
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 4, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # VA0DYWX, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # VA0DYWX, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY PRIOR TO THE REPORT THE PATIENT EXPERIENCED A SUDDEN ONSET OF SEVERE, VERY VIOLENT DYSKINESIA. THE PATIENT STATED THAT IT STARTED IN HER FACE AND THEN AFFECTED HER LEFT LEG AND ARM AND LASTED ABOUT ONE AND A HALF HOURS. THE PATIENT NOTED THAT SHE JUST COMPLETED HER ACUPUNCTURE SESSION AND WAS IN THE LOBBY PAYING FOR IT WHEN THIS STARTED. THE PATIENT WAS TAKEN TO THE HOSPITAL VIA AMBULANCE AND IT SEEMED TO RELAX HER SYMPTOMS WHEN THEY PLACED A CARDIAC CONTROL MAGNET OVER HER IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT¿S LEGS FIRST CALMED DOWN AND THEN ABOUT FIFTEEN MINUTES LATER HER ARMS CALMED DOWN. THE PATIENT STATED THAT DURING THE ACUPUNCTURE SESSION HER INS WAS ON AND SHE CHECKED IT WHEN SHE ARRIVED HOME FROM THE HOSPITAL AND IT WAS STILL ON. THE PATIENT NOTED THAT THIS WAS A STANDARD ACUPUNCTURE TREATMENT AND SHE HAD BEEN RECEIVING THESE FOR ABOUT SIX YEARS. NO NEEDLES WERE PLACED BY HER NECK AREA. THE PATIENT NOTED THAT THE ACUPUNCTURIST USED AN OINTMENT, A HOMEOPATHIC VERSION OF BENGAY, DURING THE SESSION THAT WAS APPLIED TO THE BACK OF HER NECK. THE PATIENT ALSO NOTED THAT SHE WENT DOWNHILL SKIING ON (B)(6) 2014 AND DID WEAR A HELMET, BUT DID HAVE A SLIGHT FALL. THE PATIENT CALLED HER DOCTOR¿S OFFICE AND WAS WAITING FOR A CALL BACK. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER REPORTED THAT CRAZY THINGS APPENED WITH THEIR DEEP BRAIN STIMULATION (DBS) INCLUDING SEIZURE LIKE EPISODES WHERE THEIR LEFT ARM AND LEG WERE FLAPPING AROUND UNCONTROLLABLY. THE PATIENT FELT LIKE THEY WERE BEING OVERSTIMULATED. THE PATIENT HAD TO GO TO THE HOSPITAL. THE EPISODES STOPPED AFTER THEY TURNED THE IMPLANTABLE NEUROSTIMULATOR OFF AND BACK ON. THE EPISODES BEGAN OCCURRING ONCE A WEEK IN (B)(6) 2014 AND WERE RESOLVED IN (B)(64) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY, BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT LISTED APPOINTMENTS FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249149 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Other