BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6068320 · Received October 31, 2016

    Report

    Report Number
    3007566237-2016-03834
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 14, 2016
    Report Date
    November 15, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DATE MFR REC WAS (B)(6) 2016.

    Description of Event or Problem · 1

    INFORMATION RECEIVED VIA A HEALTHCARE PROFESSIONAL FROM A CLINICAL STUDY REPORTED VIA A REPRESENTATIVE THAT UNEXPECTED NOISE WAS OBSERVED ON THE RECORDED LFP SIGNALS (POWER CHANNEL) AFTER FW UPDATE WAS PERFORMED ON (B)(6) 2016. NO ADVERSE EVENT WAS OBSERVED WITH THE PATIENT. TROUBLESHOOTING INVOLVED DIFFERENT SENSING CONFIGURATIONS BEING TESTED THE SAME DAY. ACTIONS/INTERVENTIONS INVOLVED THE IMPLANTABLE NEUROSTIMULATOR BEING INTERROGATED WITH THE SENSING PROGRAMMER AND RESTORE FW UPDATER SYSTEM ON (B)(6) 2016. DIFFERENT STIMULATION SETTINGS WERE CHANGED WITH THE CLINICIAN PROGRAMMER. THE CAUSE OF THE EVENT HAD NOT BEEN DETERMINED AND WAS STILL BEING INVESTIGATED. THE REPORT OF UNEXPECTED NOISE OBSERVED ON THE RECORDED LFP SIGNALS HAD NOT BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718026 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37604

    Patients

    Seq Age Sex Outcome Treatment
    1