BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4152875 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18525
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708640, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # VA0JQXA, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE IMPEDANCE ISSUE WAS DETERMINED AND IT WAS A TRAINING ISSUE WITH THE HEALTHCARE PROFESSIONAL (HCP). THERE WAS NO PROBLEM WITH THE SYSTEM. THE PATIENT WAS DOING WELL AND THEY WERE RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS HIGH IMPEDANCE. THE ELECTRODE IMPEDANCES FOR 0 <(>&<)>C, 2<(>&<)>C, 3<(>&<)>C, 0<(>&<)>2, 0<(>&<)>3, AND 2<(>&<)>3 WERE ALL IN HIGH RANGE. THEY WERE CURRENTLY SET ON 1- C+ WHICH WAS THE ONLY ELECTRODE COMBINATION THAT WAS NOT IN THE HIGH IMPEDANCE RANGE. THE MANUFACTURER REPRESENTATIVE WAS GOING TO ARRANGE A TROUBLESHOOTING MEETING WITH THE PHYSICIAN. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY AND THERE WERE NO PATIENT SYMPTOMS REPORTED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630425 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1