BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETRA

    MDR report key: 3202834 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11232
    Event Type
    Death
    Date Received
    July 2, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387-40, LOT# J0421698V, IMPLANTED: 2005-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387-40, LOT# J0421701V, IMPLANTED: 2005-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 7436, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED IN (B)(6) 2012. IT WAS NOTED THE PATIENT WAS HAPPY WITH THE IMPLANT SURGERY BUT STARTED TO GET DEMENTIA AT THAT POINT. THE CAUSE OF DEATH WAS FAILURE TO THRIVE; "THE PATIENT COULD NOT MOVE, THEN HE WAS NOT EATING, AND HE KEPT LOSING LIKE FIVE POUNDS AT WEEK." IT WAS NOTED THE PATIENT¿S WIFE THOUGHT THE PATIENT¿S DEATH WAS DEVICE RELATED BUT SHE DID NOT THINK HIS PHYSICIAN WOULD SAY IT WAS RELATED. A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302485 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death