These health related articles on cardiac news come from my need to stay abreast (pun intended) of current trends, studies, treatments and failures.
I suffer congestive heart failure, chronic angina, rhythm abnormalities, and severe danger of SDS (sudden death syndrome - not the more fun sexually transmitted disease - at least it is more fun to catch). More than two years ago I was implanted with a Medtronic ICD and pacing device. It stabilized some problems and "living in the Mexican jungle" said my cardiologist in Miami; provided insurance that there would be a defibrillator no more than five minutes away. The closest one to Bacalar, Mexico is probably four or five hours away.
A year ago it was replaced with a Guidant "bi-ventricular pacing device with an ICD" (internal cardioversion defibrillator) and the third lead threaded though veins into another chamber of the heart. The beating of the heart's chambers would be synchronized. Voilà!. It worked. I have more energy, a higher "ejection fraction", more ability to weather the stresses of life in the third world. It was almost miraculous.
However, some months ago I wrote of a joint study by the FDA. and Harvard that indicated " that there were an increasing number of recalls, defects, malfunctions and deaths in persons in whom automatic defibrillators had been implanted." This story on Heart Device Recall was an earlier version before this legal case and new revelations.
copyright byThe Stay Well Company
The leader of the study from Harvard, Dr. William Maisel also pointed out that in the period 1990-2002, 2,250,000 pacemakers and 416,000 ICDs had been buried in U.S. chests. 17,000 needed removal.
The scary part of the study was that half of the units that were working badly began to dysfunction at the end of the time period. The FDA promises new ways to regulate the manufacture of these machines...
This week Reuters reported that Guidant Corporation admitted that "some persons may die as result of short circuits" according to a New York Times report which cited Guidant company records.
The documents were filed in Texas where a lawsuit is in progress centered on Guidant's Prizm 2 DR defibrillator. The company was said to have previously decided that the rare failure, although "life threatening" was at an overall "acceptable rate". They did not notify doctors until last spring. The New York Times emailed Guidant where a spokesman said the "...company's policy is to not comment on pending litigation."
In October of this year, while having my six-month tune-up in the office of my electrophysiologist, Dr. Efrain Gonzalez, in Miami, I brought the subject up and Efrain said basically that it was a media exaggeration. He is probably right since I do have great faith in his integrity and competence. My machine is working. I have seen amazing improvement in heart function where there has never been the possibility of improvement in past years.
Article comments
1 - Lisa McKay
Alpha, I think you're quite right that treating any illness at this level of severity is not without risk, and you're also correct to state that the FDA needs to continue to monitor things. I believe it's also incumbent upon the companies that manufacture such devices to exercise full disclosure.
Any medical technology that allows you to share your experiences with us at Blogcritics is a good one, in my opinion. Nice piece!
2 - l larry
i have a guidant defibrilator.
it is the second one implanted i in me. it isnt one of the ones
recalled. i have had some problems
with several shocks in one day.
the docs either changed my meds
i have a guidant defibrillator,
this is the second one that i
have had implanted. i have had
some problems with continuos
shocks in one day.the docs
either change my meds or
reprogram the aicd.i look at
this is saving me a ride with
the paramedics.the treatment
is a b---h and it scares
people around me.i feel this
is a situation of sacrifice sacri a few to save many larry