BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3953595 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13443
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 22, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT¿S DEVICE WAS STARTED FOUR DAYS AFTER IMPLANT THAT ¿THE PATIENT WAS MORBUS ASTHENICUS AND COULD NOT TAKE CARE OF HIMSELF IN DAILY LIFE.¿ IT WAS STATED THAT ON (B)(6) 2014 THE PATIENT WAS REPROGRAMMED AND THEIR SYMPTOMS IMPROVED. IT WAS NOTED THAT AT THE TIME OF REPROGRAMMING ¿THE IMPLANTATION PLACE WAS SUBFEBRILE.¿ ADDITIONAL INFORMATION INDICATED THAT THE ¿MORBUS ASTHENICUS¿ CONDITION THAT WAS INITIALLY REPORTED MEANT ¿GENERAL WEAKNESS.¿ IT WAS NOTED THE PATIENT CONTINUED NOT TO RECEIVE EFFECTIVE THERAPY AT THE TIME OF FOLLOW-UP. ADDITIONAL INFORMATION INDICATED THE PREVIOUSLY REPORTED INFORMATION STATING ¿THE IMPLANTATION PLACE WAS SUBFEBRILE¿ MEANT ¿THE PATIENT FELT HEAT IN THE IMPLANTED PLACE ON THEIR CHEST.¿ IT WAS NOTED THE PATIENT DID NOT HAVE A FEVER WHEN THEY REPORTED FOR THE IMPLANT OF THEIR BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430341 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR