BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2342953 · Received November 19, 2011

    Report

    Report Number
    3004209178-2011-09299
    Event Type
    Malfunction
    Date Received
    November 19, 2011
    Report Date
    October 31, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    LEAD MODEL 748251, LOT# V012773, IMPLANTED: (B)(6)-2006, EXPLANTED: UNK, LEAD MODEL 748251, LOT# V012773, IMPLANTED: (B)(6)-2006, EXPLANTED: UNK, EXTENSION MODEL 748251, SERIAL# (B)(4), IMPLANTED: (B)(6)-2006, EXPLANTED: UNK, EXTENSION MODEL 748251, SERIAL# (B)(4), IMPLANTED: (B)(6)-2006, EXPLANTED: UNK, PROGRAMMER MODEL 37642, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS ON A PROGRAM TO INCREASE STIMULATION BY 0.1V EVER WEEK. PATIENT HAD SUCCESSFUL INCREASES OF STIMULATION DURING THE FIRST TWO WEEKS OF PROGRAMMING. THE THIRD WEEK'S PROGRAMMING TO INCREASE STIMULATION RESULTED IN A CALL YOUR DOCTOR AND OUT OF REGULATION(OOR) DISPLAY ON THE PATIENT PROGRAMMER. LOW OUT OF RANGE IMPEDANCE VALUES WERE FOUND AT ELECTRODES 0-1 = 193 OHMS, 0-3 = 165OHMS, 1-3 = 244OHMS. PATIENT WAS CONSIDERING RE-PROGRAMMING TO DIFFERENT ELECTRODES BUT WAS STILL RECEIVING GOOD THERAPEUTIC RESULTS FROM CURRENT PROGRAM SETTINGS: 3+, 1- AT 3.6V, PW OF 90 AND 130HZ. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SEEN BY THE MANUFACTURER'S REPRESENTATIVE IN (B)(6) 2011. THE PATIENT HAD AN OPEN CIRCUIT WITH THEIR ELECTRODE CONFIGURATION. THEY WERE ABLE TO PROGRAM AROUND THE OPEN CIRCUIT. THE PATIENT WAS DOING MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR