BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1941982 · Received October 18, 2010

    Report

    Report Number
    3004209178-2010-08045
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2009 THAT WHILE THE DEVICE WAS TURNED ON, A PT FELT THEY WERE EITHER UNDER OR OVER STIMULATED. ON (B)(6) 2010, IT WAS LATER REPORTED THAT THE PATIENT'S BALANCE WAS WORSE, AS THERE WAS "UNEVENNESS IN THE TRANSMISSION IN THE BRAIN". BALANCE SEEMED TO IMPROVE WHEN THE PT WAS AWAY FROM HOME AND AWAY FROM A "SMART METER". THE PT ALSO FELT "DISTRACTED" WHEN THEY WERE HOME. NO THERAPY ADJUSTMENTS WERE MADE VIA THE PT PROGRAMMER. SINCE JUNE, THE PT NOTED THAT THINGS HAVE GRADUALLY GOTTEN WORSE REGARDING BALANCE AND DISTRACTION. ON (B)(6) 2010, A LOSS OF THERAPEUTIC EFFECT WAS REPORTED. THE PT STATED HE STARTED EXPERIENCING SYMPTOMS WHEN A SMART METER WAS INSTALLED IN HIS HOUSE. IT WAS NOTED THAT THE POWER COMPANY REFUSED TO TURN OFF THE SMART METER WITHOUT A MEDICAL LETTER. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR EXTENSION: MODEL 37085, LOT# NKN000800V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V220334| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN000799V| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V238063| IMPLANTED:| EXPLANTED:| EXPLANTED: