When a Company like Medtronics produces a defective product which has the potential to cause serious injury or death to hundreds innocent members of the public worldwide there doesn’t seem to be the interest in the issue. Allegedly in March 2007 doctors were warned by the MHRA in the UK that these leads could brake when being implanted and still 268000 were installed until after the first 5 deaths were reported when Medtronics recalled the products.It is not until death and destruction has been caused that governments worldwide wake up to the facts and decide to do something about it somewhere down the line. In the meantime the individual is left with at least a life changing terrible experience and some with permanent serious injury or death and with it indivdual potential legal action.
MHRA said "Medtronic had previously issued a ‘Physician Information Letter’ on this lead family in March 2007. Their investigations at that time concluded that variables within the implant procedure may predispose the lead to fracture, with severe bending or kinking of the lead during implantation using the venous access location identified as a risk factor."
Medtronics Corporation and Medtronics Limited in the UK have recalled hundreds of thousands of Pacemaker Leads worldwide. In the USA , UK and the rest of the world we have large numbers of leads implanted with a serious risk of fracturing whist implanted in the Hearts of People. Unfortunately many of these defective Pacemaker leads have already been implanted and to take them out may pose a serious risk to life. In USA, of course, action is already been taken by large numbers of people who have been affected by this faulty product to seek compensation from Medtronics for the trouble which they caused with much more to come. Increasingly this problem is coming to light in other countries where the suspect defibrillator leads have been installed
An ICD defibrillator is an implanted device designed to give shocks to restart the Heart when it is not functioning properly and when a lead fractures the device delivers shocks because it is no longer receiving information the heart is beating and will go on doing that as long as the battery has power left in it.
My Medtronics CRT-D Pacemaker was originally fitted at The John Radcliffe Hospital in Oxford England in May 2007. It did what it was supposed to do and with online downloads from home and annual check ups at the John Radcliffe clinic all was well. A few months after it was fitted I was called into clinic and told that I should listen for an alarm at 9.30 am each morning when the device would conduct a lead check. I should report any lead check alarm No such alarm ever took place.
On the18th August 2010 out of the blue, my implanted Pacemaker / defibrillator (CRT-D)(ICD) delivered 6 shocks at random: I was knocked down, in a lot of pain - thought I was dying and fortunately my wife was in the house and able to call an ambulance to take me to the John Radcliffe Hospital in Oxford: I dread to think what would have happened if I had been a few hours away from the John Radcliffe. Unfortunately the ambulance people were not equipped to turn off the device and shocks continued all the way to the Hospital. They were immediately able to switch off the ICD part of the CRT-D and informed me that it was a fractured lead which caused the problem: I subsequently had a replacement pacemaker and a new lead was added to take over the function of the fractured lead: All done I have to say very quickly and efficiently. Unfortunately a few days later I suffered from a Heart Attack. I still have all of the other original leads connected and cannot be sure if these will fracture in the future.
The problem as I understand it is that at the John Radcliffe Hospital alone there have been about 120 of these devices implanted and they expect 12 – 14 of them to fail due to the defective product produced by Medtronics.
In my own case seconds later I would have been walking downstairs. One day later I would have been driving on a motorway. What would I have done if I were on a long airplane journey unable to do anything to turn the device off?
It is not enough just to offer best practice at Hospital because many of us will have problems long before we get to Hospital if we get there. At the very least all of people who have had these 268000 defective leads implanted (6900 in the UK) in spite of the recall are real people who deserve to be told exactly what has happened. Despite all Medical alerts the Hospital never told me about the danger so I knew what to expect. What happened to Human Rights? The Hospital should have taken notice of the warning in March 2007 and avoided using a product which might break when implanted. Surely there were alternative products which they could have used. Then as soon as the first medical alert was issued in October 2007 I should have been told immediately and given the option to have the defective lead capped off and a new lead added taking away all of the danger. Nobody monitors a time bomb just waiting for it to go off without taking action.
All people involved should receive a free magnet from Medtronics and be shown how to use it in an emergency. All ambulances should carry a magnet on board so that they can stop the shocks when they are inappropriate. President Obama, David Cameron and leaders of other affected countries should act together to insist that Medtronics set up a fund to pay compensation to the people affected by this problem. Why are they allowing people to be put at risk of causing a public accident. Why is'nt the public protected by fixing the probem. There are public Health and Safety issues to consider. These pacemaker leads will continue to fracture at an increasing rate as time passes and to do nothing other than to fix members of the public after an accident has occured is not a responsible position to take. Some reports suggest a 9.2% failure rate and there is a suggestion of the failure rate increasing with time to up to 30% of the figures above. This Global problem needs a Global solution and cannot just be left to Lawyers although they have to get involved.
If you would like to share your own experience on this issue please send your email to me at
heartshocked@gmail.com
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