BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3102716 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07441
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 10, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37603 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID: 3389S-40 LOT# VA04KN5, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3389S-40 LOT# VA04SYK, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3389S-40 LOT# VA04KN5, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3389S-40 LOT# VA04SYK, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER THE PATIENT'S DEVICE WAS TURNED ON THE PATIENT "HAD NOT BEEN THE SAME, HIS COGNITIVE SKILLS WERE NOT EVEN CLOSE TO WHAT THEY WERE BEFORE SURGERY AND HIS SPEECH WAS TERRIBLE." IT WAS ALSO REPORTED ONE OF THE PATIENT'S ARMS WAS STILL TREMORING BUT THE OTHER WAS DOING GREAT. REPROGRAMMING WAS UNABLE TO CONTROL THE PATIENT'S TREMORING ARM AND STIMULATION COULD NOT BE TURNED UP BECAUSE IT WAS AFFECTED "THE DRAWING OF THE PATIENT'S MOUTH"; THE PATIENT'S SPOUSE FELT THIS INDICATED THE PLACEMENT "WAS NOT RIGHT." IT WAS REPORTED, THE PATIENT'S SURGERY LASTED 3 HOURS LONGER THAN EXPECTED AND THE PATIENT'S SPOUSE WAS WORRIED IF THAT COULD HAVE CAUSED DAMAGE TO THE PATIENT. FOLLOWING IMPLANT IT WAS NOTED THE PATIENT'S THINKING AND COGNITION WAS "STILL REALLY GOOD," BUT AFTER THE DEVICE WAS TURNED ON THE PATIENT STARTED "FORGETTING TO TURN THE WATER AND LIGHTS OFF AND RAN INTO A TELEPHONE POLE WHILE MOWING THE YARD." IT WAS ALSO REPORTED, THE PATIENT "USED TO BE A WALKING COMPUTER AND NOW HE COULD NOT EVEN COUNT, HARDLY FOR A THREE-NUMBER DIGIT LIKE TWENTY AND TWENTY." IT WAS REPORTED THE FIRST TIME THE PATIENT CAME HOME AFTER THE DEVICE WAS TURNED ON HE WAS "DRAGGING HIS LEG LIKE WHEN SHOVELING SNOW AND THE PATIENT WAS TO THE POINT WHERE HE COULD HARDLY GET UP OUT OF BED." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202902 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability