BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4243253 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21303
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37642, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3389-40, LOT# J0206490V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT# J0206490V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT, TINGLING IN THEIR FACE THAT STARTED A COUPLE MONTHS PRIOR TO THIS REPORT, AND AN ISSUE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿NOT READING.¿ THE PATIENT STATED ¿THEY WERE SO OFF THAT THEY COULD NOT STAND IT.¿ SINCE THE PATIENT MOVED NEXT TO AN ELECTRICAL CLOSET IN (B)(6) 2014 THEIR PARKINSON¿S SYMPTOMS HAD GOTTEN WORSE. THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) HAD INCREASED THEIR ORAL MEDICATION. THE PATIENT FELT THE TINGLING FROM THEIR FOREHEAD ON THE LEFT SIDE TO ALL THE WAY DOWN UNDER THEIR CHIN. THE TINGLING WAS ERRATIC AND DID NOT HAPPEN ALL OF THE TIME. THE PATIENT FURTHER DESCRIBED THE TINGLING SENSATION AS ¿IF YOU WENT TO SLEEP AND WOKE UP WITH A TINGLING FEELING THAT DID NOT LAST VERY LONG.¿ THE PATIENT HAD GONE TO THEIR HCP WHO CHECKED THE SETTINGS AND EVERYTHING WAS FINE. THE HCP COULD NOT SEE ANY REASON FOR THE TINGLING. THE PATIENT NEEDED A BATTERY FOR THE PATIENT PROGRAMMER AND DID NOT GET IT IN RIGHT AWAY. THE PATIENT WONDERED IF THAT HAD AFFECTED THEIR SETTINGS. WHEN THE PATIENT TURNED THE PROGRAMMER ON THE SCREEN CAME ON AND HAD A CHECKMARK. WHEN THE PROGRAMMER WAS PLACED OVER THE INS, THE PATIENT SAW THE INS WAS ON AND OKAY AT 3.68 AND 2.70. FOLLOW UP WITH THE PATIENT¿S HCP INDICATED THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT DID NOT HAVE A 50% OR GREATER SYMPTOM REDUCTION AND REPROGRAMMING WAS NOT NEEDED. THE PATIENT DID NOT HAVE A LOSS OF THERAPEUTIC EFFECT OR A LOSS OF STIMULATION. THE PATIENT¿S SYMPTOMS WERE INTERMITTENT AND NO INTERVENTION WAS NECESSARY. THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725835 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR