BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2722759 · Received August 31, 2012

    Report

    Report Number
    3004209178-2012-07592
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Report Date
    August 1, 2012
    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 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT THEY FELT 'WEAKNESS ALL OVER' THAT BEGAN ON (B)(6) 2012. THE PATIENT REPORTED FEELING SYMPTOMS 'ALL OVER HER BODY.' IT WAS NOTED THAT THE PATIENT 'WAS AT CHURCH AND USING A WALKIE-TALKIE' AT THE TIME OF THE INCIDENT. THE PATIENT ALSO STATED THAT SHE 'FORGOT TO TAKE HER MEDICATION THIS AFTERNOON.' IT WAS NOTED THAT THE PATIENT WOULD LIKE ASSISTANCE TO DETERMINE IF HER THERAPY WAS ON. BASIC FUNCTIONALITY OF THE DEVICE WAS REVIEWED. IT WAS NOTED THAT 'AFTER A FEW MINUTES OF TURNING THE STIMULATION BACK ON AGAIN, THE PATIENT WAS FEELING MUCH BETTER.'

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1