BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3041461 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04890
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37085-95, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-95, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V488642, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V476623, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE DEVICE WAS "NOT WORKING PROPERLY", AND BY NOT WORKING PROPERLY, THE PATIENT MEANT HE HAD BEEN REPROGRAMMED FOR A "LITTLE BIT AROUND (B)(6) 2012 AND IT DIDN'T LAST LONG AT ALL. IT LASTED FOR ABOUT THREE WEEKS AND NOW HIS RIGHT SIDE WAS RIGHT BACK TO THE WAY IT WAS BEFORE THE PATIENT EVEN HAD THE DEVICE PUT IN." THE PATIENT NOTED HE HAD BEEN "LOCKED UP" FOR THE PAST YEAR. IT WAS NOTED THE PATIENT'S DEVICE WAS ON AT THE TIME OF THE CALL. IT WAS LATER REPORTED ON (B)(6) 2013 THE CAUSE OF THE EVENT WAS THE PATIENT COMPLAINING OF "SHOCKING AND WORSE TREMOR." IT WAS STATED ON (B)(6) 2013 THE PATIENT WAS REPROGRAMMED WITH A "GOOD OUTCOME" AND COULD HOLD A CUP WITHOUT ANY TREMORS. IT WAS ALSO STATED THE PATIENT HAD NOT HAD ANY TREMORS AFTER REPROGRAMMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE PATIENT REPORTED THAT THEY STILL HAD CONCERNS REGARDING THEIR THERAPY/DEVICE BUT HAD NOT SOUGHT FURTHER HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143814 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1