BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4334477 · Received December 16, 2014

    Report

    Report Number
    3004209178-2014-24072
    Event Type
    Injury
    Date Received
    December 16, 2014
    Report Date
    November 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V130906, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V130906, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V130906, IMPLANTED:(B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4),IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V130906, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS UNCLEAR IF IT WAS DEEP BRAIN STIMULATOR RELATED. THE PATIENT HAD EPISODES OF STARRING, EYES OPEN, NOT RESPONDING TO HIS WIFE AND CONFUSION. THIS HAD BEGUN 1 WEEK PRIOR TO THANKSGIVING. THE PATIENT WAS BETTER AFTER THEY HAD STARTED ON KEPPRA. AN ELECTROENCEPHALOGRAPHY (EEG) AND MRI WERE PENDING. THE PATIENT WAS NOW ON ANTI-SEIZURE MEDICATIONS. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SEIZURES AND IT WAS UNKNOWN WHY. THEY HAD NOT THOUGHT THAT THE SEIZURES WERE RELATED TO THE DEEP BRAIN STIMULATOR THERAPY. THE PATIENT WAS NOT HAVING ¿FULL BLOWN¿ SEIZURES, ONLY PARTIAL SEIZURES. THE PATIENT HAD BEEN HAVING THESE FOR THE PAST 4-5 WEEKS PRIOR TO THE DATE OF THIS REPORT. THE PATIENT¿S HEALTHCARE PROFESSIONAL WANTED TO DO AN ELECTROENCEPHALOGRAPHY (EEG) TO SEE IF THEY COULD FIND THE CAUSE OF THE SEIZURES. THE PATIENT HAD BEEN IN THE EMERGENCY ROOM ON (B)(6) 2014 AND AGAIN ON MONDAY AND TUESDAY PRIOR TO THE DATE OF THIS REPORT BECAUSE HE HAD NOT BEEN FEELING WELL. NO INTERVENTION OR OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822400 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Other