BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4791499 · Received May 22, 2015

    Report

    Report Number
    9614453-2015-01051
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 4, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387-28, LOT# 0209168926, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-28, LOT# 0209198775, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT WHEN THE PATIENT'S PHYSICIAN "ATTEMPTED TO PROGRAM THE PATIENT POST-OPERATIVELY, HE COULD NOT USE CONTACT 10." THEN THE PHYSICIAN ATTEMPTED TO PROGRAM THE PATIENT'S RIGHT SUBTHALAMIC NUCLEUS (STN) LEAD, "HE NOTICED A POOR RESPONSE." IMPEDANCE TESTING WAS PERFORMED AND FOUND THAT CONTACT 10 "HAD IMPEDANCES GREATER THAN 40000" OHMS. THE PHYSICIAN "PROGRAMMED AROUND THE INVALID CONTACT" AT THAT TIME AND THE PATIENT WAS "RECEIVING BENEFICIAL STIMULATION" FOLLOWING THE PROGRAMMING. THOUGH THE ISSUE WAS NOT RESOLVED, SURGICAL INTERVENTION WAS NOT PLANNED OR UNDERTAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE OBSERVED DURING POST-OPERATIVE PROGRAMMING. IMPEDANCE TESTING FOUND THAT UNIPOLAR ELECTRODE 10 AND ALL BIPOLAR ELECTRODE PAIRS INVOLVING ELECTRODE 10 HAD HIGH IMPEDANCES OF ¿>40000¿ OHMS. THE PROGRAMMING PHYSICIAN WAS REPORTED ¿UNABLE¿ TO PROGRAM THE PATIENT INITIALLY AFTER THE OPERATION ¿DUE TO THE HIGH IMPEDANCES ON CONTACT 10.¿ IT WAS UNKNOWN WHICH DEVICE COMPONENT WAS THE CAUSE OF THE IMPEDANCE ISSUE. THE PATIENT WAS SUBSEQUENTLY PROGRAMMED ON THEIR RIGHT SIDE USING ELECTRODE 9, WHICH WAS NOTABLY ¿HELPING AND PROVIDING THERAPY.¿ THERE WERE ¿NO¿ PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334982 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR