Medtronic Defibrillator Lead Recall not the first Problem for ICD Manufacturers

Image source: http://www.heart-lead-recall.com/media/2013/10/defibrillator-lead-recall.png

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.