Medtronic Defibrillator Lead Recall not the first Problem for ICD Manufacturers

Medtronic Defibrillator Lead Recall not the first Problem for ICD Manufacturers
Over the last few years defibrillators and pacemakers have
been the subject of several news provoking recalls.
Defibrillators and pacemakers are known as implantable
cardiac defibrillators or ICDs. ICDs are electronic devices
that constantly monitor your heart rate and rhythm. When it
detects a very fast, abnormal heart rhythm, it delivers
energy to the heart muscle. This causes the heart to beat
in a normal rhythm again.

The failure of an ICD to provide the necessary energy to
the heart can result in serious injury or death. Thousands
of Americans rely on these devices to literally keep them
alive. Understandably, the frequency of recalls for ICDs
and their components has been a source of much concern for
heart patients and their physicians.

In June 2005, Guidant Corp. issued a series of recalls for
many of their implantable pacemaker models. Throughout 2005
and 2006 Guidant recalled 22 different models:

· Contak Renewal

· Contak Renewal 2

· Contak Renewal 3

· Contak Renewal 3 AVT

· Contak Renewal 4

· Contak Renewal 4 AVT

· Contak TR

· Discovery

· Discovery II

· Insignia

· Intelis II

· Meridian

· Nexus

· Pulsar

· Pulsar Max II

· Renewal 3 AVT

· Renewal 4 AVT

· Renewal RF

· Ventak Prizm 2 DR

· Ventak Prizm AVT

· Virtus Plus II

· Vitality AVT

Guidant wasn't the only ICD manufacturer that had problems
with their defibrillators. On February 3, 2005, Medtronic
announced the recall of several models of ICDs because of
battery problems which could cause them to fail. The recall
involved Medtronic's Marquis line of ICDs, which included
the following models:

· Micro Jewel II Model 7223Cx

· GEM DR Model 7271 ICDs

· 7230 Marquis VR

· 7274 Marquis DR

· 7232 Maximo VR

· 7278 Maximo DR

· 7277 InSync Marquis

· 7289 InSync II Marquis

· 7279 InSync III Marquis

In December 2007, Medtronic Corp announced that it agreed
to settle 2,682 legal cases related to these recalled
defibrillators for $114 million. $95.6 million plus $18.5
million The settlement came after Medtronic's attempt to
have the lawsuits dismissed failed in November 2006, when a
U.S. district court denied its request.

On October 15, 2007 Medtronic Corp recalled its Sprint
Fidelis defibrillator leads because they can fracture and
cause an ICD to issue unnecessary shocks or not provide
needed shocks. A defibrillator lead connects an ICD to the
heart, if a lead fractures it can send misinformation the
ICD and cause serious complications. The recall involves
the following Medtronic Sprint Fidelis models:

· Sprint Fidelis 6930

· Sprint Fidelis 6931

· Sprint Fidelis 6948

· Sprint Fidelis 6949

Medtronic has said that most patients will not need to have
their leads replaced. The company believes that
reprogramming devices for most patients will alleviate the
increased risk posed by defective leads. However, this
"solution" is not sitting well with many patients with
recalled leads; these patients would prefer undergoing lead
replacement surgery to have peace of mind.

The ICD market is already huge and quickly growing. In fact
the market is so lucrative that there was a bidding war for
Guidant Corp. even after the company recalled thousands of
their devices. Johnson & Johnson and Boston Scientific were
undeterred by the potential fallout over the recalls and
both offered aggressive bids for the company. Boston
Scientific finally outbid Johnson & Johnson and purchased
the company for $25 billion dollars.

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The recall of thousands of defibrillators over the last few
years has alarmed many heart patients and doctors. The
issue has come to light again when Medtronic recalled its
Sprint Fidelis defibrillator leads. In 2005, Medtronic
recalled its Marquis line of ICDs. In 2005, Guidant Corp.
also recalled thousands of defibrillators and pacemakers.
http://www.youhaverights.com/medical-devices/medtronic-sprin
t-fidelis-defibrillation-leads