BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4953115 · Received July 30, 2015

    Report

    Report Number
    3004209178-2015-14361
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 9, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-40, LOT# V004235, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 64002, LOT# N242113, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER; PRODUCT ID 3389-40, LOT# V004235, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INTERMITTENT THERAPY AND THE PATIENT'S SYMPTOMS WERE ON AND OFF. THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN ON AND OFF. THE PATIENT'S LEG WAS GIVING OUT ON THEM AND THEIR BRAIN WAS NOT FUNCTIONING WELL LIKE THE PATIENT WAS OUT IF IT. THE PATIENT HAD TO CRAWL TO THE BATHROOM. THE REPORT STATED THAT IT HAD BEEN ABOUT TWO WEEKS SINCE THE PATIENT EXHIBITED SYMPTOMS. AT THE TIME OF THIS REPORT, THE PATIENT'S THERAPY WAS ON AND OKAY AT 2.9V. LAST WEEK THE PATIENT'S THERAPY WAS AT 2.9V. AN APPOINTMENT WITH THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) WAS SCHEDULED. 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
    498705 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR