BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6241739 · Received January 11, 2017

    Report

    Report Number
    3004209178-2017-00625
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    September 15, 2016
    Report Date
    January 11, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT WHEN THEY WERE PROGRAMMING THE PATIENT, THE PROGRAMMING SUDDENLY WENT FROM VOLTAGE MODE TO CURRENT MODE AS OF 3 MONTHS PRIOR TO DATE NOTIFIED. AS A RESULT THE PATIENT GOT A "ZING" FROM IT, SO THE HCP LEFT THE PATIENT IN CURRENT MODE. IT WAS STATED THAT THE PATIENT WAS RUNNING INTO UPPER MOTOR NEURON SIDE EFFECTS WITH VOLTAGE MODE, BUT THAT WENT AWAY WHEN THE PATIENT WAS IN CURRENT MODE. THE PATIENT WAS NOW USING LESS VOLTAGE THAN BEFORE THE SUDDEN CHANGE TO CURRENT MODE, WITH BETTER SYMPTOM CONTROL. LONGEVITY CALCULATIONS WERE RUN WHICH SHOWED THE PATIENT HAS 3 MONTHS FROM ERI TO EOS. THE PATIENT'S INDICATION FOR IMPLANT IS MOVEMENT DISORDERS. SEE RELATED REGULATORY REPORT 3004209178-2017-00624.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26458 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR