BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 4812231 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10111
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 12, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3389S-40, LOT# V158028, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V157361, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND SHAKING FOLLOWING AN UNRELATED MEDICAL PROCEDURE. THE PATIENT WENT TO THE EMERGENCY ROOM LAST WEDNESDAY OR THURSDAY DUE TO CONGESTIVE HEART FAILURE AND THEY NEEDED AND ELECTROCARDIOGRAM (ECG). THE PATIENT HAD SHAKING ON THE LEFT SIDE OF THEIR BODY SINCE THE ECG. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF FOR THE ECG. WHEN ASKED IF THE PATIENT HAD BEEN SHAKING SINCE THE ECG, THE REPORTER STATED YES AND NO AND THE PATIENT HAS ANXIETY ATTACKS. THE REPORTER FURTHER STATED THE PATIENT WAS SHAKING PRIOR TO GOING TO THE EMERGENCY ROOM AND IT JUST DEPENDS. THE REPORTER STATED THE INS MAY NOT HAVE BEEN TURNED BACK ON PROPERLY. THE RIGHT LEAD WAS SET BETWEEN 1.7 AND 2.5V AND THE HEALTHCARE PROFESSIONAL (HCP) PUT IT AT 1.9V. THE LEFT LEAD WAS ¿LOCKED IN¿ AT 2.6V. THE REPORTER CHECKED THE INS WITH THE PATIENT PROGRAMMER AND ALL THREE LIGHTS WERE ON INDICATING THE INS WAS ON. THE MORNING OF THIS REPORT, THE PATIENT WAS ¿MESSING¿ WITH THE PATIENT PROGRAMMER AND THE LIGHT WAS YELLOW/AMBER. THE REPORTER HAD PRESSED THE ON KEY TO TURN THE INS BACK ON THE MORNING OF THIS REPORT OR ¿THEIR SON NEVER TURNED THE INS BACK ON¿ AFTER THE ECG. THE PATIENT¿S LEG WAS NOT SHAKING AT THE TIME OF THIS REPORT. THE PATIENT HAD STIFFNESS IN THEIR LEFT LEG AND REPORTER WANTED TO KNOW WHY. THE PATIENT WAS TAKING 100 MG OF CARBOLEVADOPA EVERY TWO HOURS AND THE REPORTER STATED THE PATIENT WAS ¿A LITTLE BIT OVERDOSING ON IT.¿ 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
    356189 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR