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:
http://www.accessdata.fda.gov/scripts/cd...
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
safe.
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.
http://www.geocities.com/christopher_coy...
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