BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6016913 · Received October 11, 2016

    Report

    Report Number
    3004209178-2016-21495
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 19, 2016
    Report Date
    November 10, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT AN OUT OF REGULATION (OOR) CODE WAS SEEN ON (B)(6) 2016, EVEN THOUGH THE SETTINGS WERE NOT TOO HIGH. THE REP MET WITH THE PATIENT TO CHECK THE SYSTEM ON (B)(6) 2016. THE IMPEDANCES WERE CHECKED AND ELECTRODE 1 WAS SHOWING GREATER THAN 10,000 OHMS, WHICH THE PATIENT WAS PROGRAMMED USING. REPROGRAMMING WAS DONE TO ELIMINATE THE USE OF ELECTRODE 1. THERE WERE NO ASSOCIATED SYMPTOMS. THE PATIENT WAS DOING FINE AFTER REPROGRAMMING. HE WAS POSSIBLY SCHEDULED FOR IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSION REPLACEMENT IN APPROXIMATELY FOUR TO FIVE MONTHS. THE REP HAD NOT SPOKEN TO THE SURGEON TO CONFIRM THE SCHEDULE. THE PATIENT¿S INDICATIONS FOR USE WERE PARKINSON¿S DUAL AND MOVEMENT DISORDERS.

    Description of Event or Problem · 1

    FOLLOW-UP WAS RECEIVED FROM A MANUFACTURERS' REPRESENTATIVE WHO REPORTED THAT THE PATIENT HAS A MAKE/BREAK CONNECTION IN HIS EXTENSION. IT WAS ADDED THAT THEY WOULD EVALUATE RELAXING THE EXTENSION WHEN THE PATIENT'S BATTERY IS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669752 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR