BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4393093 · Received January 7, 2015

    Report

    Report Number
    3004209178-2015-00259
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Report Date
    December 15, 2014
    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
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A ¿BURNING SENSATION AT HER IMPLANTABLE NEUROSTIMULATOR (INS) SITE WHEN THE VOLTAGE WAS INCREASED TO 3 VOLTS OR ABOVE.¿ THE PATIENT¿S VOLTAGE WAS SET TO BELOW 3 VOLTS AT THE TIME OF REPORT ¿IN ORDER TO RELIEF SUCH SENSATION.¿ THE PATIENT WAS REPORTEDLY ¿RECEIVING EFFECTIVE THERAPY;¿ HOWEVER, SHE ¿COULDN¿T OPTIMIZE THE THERAPEUTIC EFFECT BY INCREASING THE VOLTAGE BECAUSE OF THE BURNING SENSATION.¿ IT WAS UNKNOWN WHETHER THE ISSUE WAS CAUSED BY THE INS AS OF FOUR DAYS AFTER INITIAL REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED ¿THE SENSATION AS ONLY PRESENT WHEN THE STIMULATOR WAS ON¿ AND THAT THE BURNING SENSATION ¿DID NOT APPEAR ALL THE DAY.¿ WHEN THE PATIENT¿S STIMULATION VOLTAGE WAS INCREASED ABOVE THREE VOLTS, IT NOTABLY ¿TOOK TIME FOR THE PATIENT TO HAVE THE FEELING.¿ IMPEDANCE TESTING WAS PERFORMED AND NOTED ¿IMPEDANCES WERE SLIGHTLY OUT OF RANGE¿ AND THAT THERE WAS ¿AN OPEN CIRCUIT.¿ THE MONOPOLAR IMPEDANCE VALUES FOR ELECTRODES 8, 9, AND 10 WERE FOUND TO BE 2532, 2180, AND 2303 OHMS RESPECTIVELY, WHILE THE BIPOLAR IMPEDANCE VALUES FOR ELECTRODE PAIRS 8-10, 8-11, AND 9-11 WERE FOUND TO BE 4050, 4161, AND 4018 OHMS RESPECTIVELY. THE PATIENT HAD NOT REPORTED ANY FALLS OR TRAUMATIC EVENTS AS OF THE TIME OF FOLLOW-UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCE WAS SLIGHTLY OUT OF RANGE ON THE RIGHT LEAD AND THERE WAS AN OPEN CIRCUIT. THE IMPEDANCES WERE GREATER THAN 2,000 OHMS FOR MONOPOLAR AND GREATER THAN 4 ,000 OHMS FOR BIPOLAR WHEN MEASURED AT 1.5V. THE FOLLOWING OUT OF RANGE IMPEDANCES WERE MEASURED: C-8 = 2532 OHMS, C-9 = 2180 OHMS, C-10 = 2303 OHMS, 8-10 = 4050 OHMS, 8-11 = 4161 OHMS, AND 9-11 = 4018 OHMS. OTHER ELECTRODE PAIRS WERE NOT ABLE TO BE TESTED DUE TO SIDE EFFECTS. THE PATIENT COULD NOT WITHSTAND THE SPASM GENERATED BY OTHER CONTACTS. X-RAYS WERE DONE AND THERE WAS NO APPARENT DAMAGE OR BREAKAGE IN THE LEAD OR EXTENSIONS. AT THE TIME OF THIS REPORT, THE PATIENT WAS USING BIPOLAR SETTINGS INSTEAD OF UNIPOLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13914 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1