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    Posted by MEDTRONIC on 2/25/07

    Please check out the report again. The report clearly
    indicates the Concerto ICD was malfunctioning. The fact
    that the device reset, and that the reset resulted in a 70-
    75 bpm (default rate) and the cardiologist "adjusted the
    malfunctioning icd to avert getting hung up at 120bpm
    tacycardia" leads me to believe the patient's heart was
    being forced into Tachycardia. According to the report,
    YES is the answer to the question "Is this a Product
    Problem Report?". The Patient outcome is hospitalization
    and "Required Intervention Disabling". Do you believe
    someone with heart problems getting their heart forced to
    120bpm heart rate from 10:30 P.M. until 2:30 A.M. would
    not be harmed?

    If that report doesn't convince you a Concerto patient was
    injured check out this report:
    Check out the very top of the report "Event Type: Injury"

    Just to be clear, I have never stated that I have evidence
    the Concerto is unsafe. My complaint is that Medtronic did
    not sufficiently test the device to know whether it is

    It's up to Medtronic to prove the incidents in question
    were not caused by an instability. Medtronic never tested
    to see whether noise from an instability could couple onto
    the rate sensor and cause tachycardia. Medtronic adopted
    some of my recommendations, but I had to resign in protest
    to get them to do that and they refused to tell me what
    they adopted as recent as two weeks ago.

    This evidence shows Medtronic is not being honest. Want
    more? Medtronic is quoted saying they haven't talked with
    the FDA in one report, but then in another they claim they
    offered the FDA additional evidence, but the FDA declined.
    That's just within the last couple weeks and it's just the
    tip of the iceberg.

    I appreciate your questions. I've answered them many, many
    times over the past couple weeks, but little has been
    published so far. Therefore, I've just started a website
    to start providing evidence to the public. I'll try to get
    to your answers before I go to bed tonight. Thanks for
    your interest.

    Posts on this thread, including this one

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