Dangerous Medical Device

Guidant Cardiac Defibrillator

Cardiac Resynchronization Therapy and Implantable Cardiac  Defibrillators Cardiac Resynchronization Therapy (CRT) pacemakers and  Implantable Cardioverter Defibrillators (ICDs) both deal with the  science of heart disease. Recently Guidant Corp. and Medtronic, Inc.,  two major manufacturers these medical devices have faced recalls  because of serious design flaws in their products.

Boston Scientific/Guidant Cardiac Defibrillator Recall

UPDATE 7/18/07:
Boston  Scientific has agreed to pay $195 million to settle claims against its Guidant  division, which purported the Guidant Corp. knowingly hid defects in its  implantable heart devices.

The  settlement resolves more than 1,500 lawsuits representing approximately 4,000  people who received defective Guidant defibrillators.

The  plaintiffs are suing for the cost of medical care, as well as the effects of  replacement or the anxiety associated with having a potentially defective  device.

A $195  million settlement would be significantly less money than Boston Scientific has  set aside to deal with its Guidant liabilities. According to a May filing with  the US Securities and Exchange Commission, the company had accrued $732 million  to pay for its legal defense and any potential settlement.

From the Boston Globe.

UPDATE 4/5/07:
On April 5, 2007, an additional 73,000 implantable cardiac  defibrillators and cardiac resynchronization therapy defibrillators were  recalled by Boston Scientific Corp. The recall is due to a flaw in the devices  that can cause the batteries to wear out sooner than expected.

UPDATE 6/26/06:
More Defibrillators, Pacemakers Recalled

Boston  Scientific Corp. warned 27,200 patients that their pacemakers and  defibrillators may fail without warning because of defective parts (low  voltage capacitors, which are used to store electrical charges). The  affected products are units in the following lines:

Pacemakers:

Insignia
Nexus

Cardiac  Resynchronization Pacemakers:

Contak Renewal TR/TR2

Implantable Defibrillators:

Ventak Prizm 2
Vitality
Vitality 2

The  faulty devices were made by Guidant Corp., which Boston Scientific  acquired in April 2006 for $27.5 billion. Four devices have already  been removed from patients. An additional 23,000 unused devices are  being recalled.

Last year, Guidant recalled 109,000  defibrillators and faced a slew of lawsuits,U.S. regulatory sanctions,  lost market share, and state investigations.

Boston Scientific  spokesman Paul Donovan says they are “recommending patients see their  doctors at the earliest opportunity.” Doctors are being advised to  check for signs of a malfunctioning capacitor, such as  prematurely  drained batteries or a device that stops working as intended to restore  a normal heart rhythm.

On June 17, 2005, the Food and Drug  Administration (FDA) reported that Guidant Corporation had recalled  certain implantable defibrillators and cardiac resynchronization  defibrillators. Guidant Corp. is an Indiana-based world leader in the  design and development of cardiovascular medical products.

On  June 24, 2005, Guidant Corp. issued a second safety advisory to warn  doctors that many of its devices may malfunction and pose serious  cardiovascular risk. The following devices are included in various  warnings issued by Guidant Corp. and the FDA:

CONTAK RENEWAL ® (Model H135)
CONTAK RENEWAL ® 2 (Model H155) manufactured on or before August 26, 2004
CONTAK RENEWAL ® 3
CONTAK RENEWAL ® 4
CONTAK RENEWAL ® RF
RENEWAL 3 AVT ®
RENEWAL 4 AVT ®
RENEWAL ® RF
VENTAK PRIZM AVT ®
VENTAK PRIZM ® 2 DR, model 1861 (manufactured before April 16, 2002)
VITALITY ® AVT

According   to a June 17, 2005, FDA news release, "These devices can develop an  internal short circuit without warning, resulting in failure to deliver  a shock when needed (1)." This warning pertains to:

PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
CONTACK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

In  a “Dear Doctor” letter dated June 23, 2005, issued by Guidant Corp.  they recommend, “doctors should discontinue implants of these devices  pending further notice (2).” The warning, and subsequent recall,  pertains to all serial numbers of the following devices:

CONTAK RENEWAL 3
CONTAK RENEWAL 4
RENEWAL 3 AVT
RENEWAL 4 AVT
RENEWAL RF

The  “Dear Doctor” letter cites, “Engineering analysis has determined that  the magnetic switch in these devices may stick in the closed position   (2)” the result of which can be device malfunction. Some of these  devices can be reprogrammed by a physician without surgical removal,  however, many would require a second surgery to replace the device,   which poses additional risks.

Understanding Heart Failure

Heart   failure affects 4.6 million Americans with some 550,000 new cases  diagnosed each year. It is the leading cause of  hospitalization for  those aged 65 and older (3). Heart failure does not mean  the heart has  stopped working, but rather that the heart is pumping blood at a   lower, slower rate. This leads to an increase of pressure inside the  heart, the result of which is the heart’s inability to pump enough  oxygen and nutrients throughout the body to meet its needs.

The  term heart  failure also encompasses conditions such as ventricular  tacycardia and  fibrillation in which the heart beats extremely fast  and without enough pressure to adequately supply the body’s needs. It  is when the heart no  longer functions properly that   many look to  medical devices to correct the dysfunction, which is where Cardiac  Resynchonization Therapy and ICDs are effective.

Cardiac Resynchronization Therapy and Implantable Cardiac Defibrillators

CRT  pacemakers and ICDs both deal with the science of heart disease. CRT  devices are an advanced form of pacemakers; their function is to  coordinate the ventricles (the main pumping chambers) of the heart to  beat in an efficient, cohesive manner. Some sufferers of heart disease  have ventricles which beat against one another and are incapable of  producing the necessary strong muscular contractions of a healthy  heart. CRT pacemakers largely alleviate this problem.

ICDs are  similar to CRT devices in that their primary function is also to  regulate the beating of the heart. ICDs deal with ventricular  tacycardia and fibrillation – when the heart beats so fast that blood   is not pumped throughout the body. This condition can also lead to  cardiac arrest and death. ICDs monitor the rhythm of the heart and will  deliver an electric shock directly to the heart if it begins to beat  dangerously fast. 90% of today’s cardiac arrests are prevented by ICDs  (4).

Who is at risk?

Guidant estimates  that 46,000 of their devices are in use worldwide. Guidant said two  deaths have occurred in patients using affected models. Additionally,  there were seven devices with 45 failures among them, with 43 occurring  in connection with the VENTAK PRIZM 2 DR, the CONTAK RENEWAL and the  CONTAK RENEWAL 2. The recall pertained to 50,000 units, but only about   half of them can be reprogrammed at a physician’s office – the other  half would require surgical removal to correct (5). Other sources say  the recall affects as many as 74,900 Guidant defibrillators (6).

The  FDA warns, “The Prizm 2 and Renewal Devices are subject to different  failures, resulting in the devices’ inability to deliver an electric  shock during episodes of arrhythmia—which could lead to a serious,  life-threatening event for a patient (7).”

What should I do if I received one of these devices?

Always  consult with your physician for medical advice. If you received one of  these devices and are concerned about the possible health risks,  contact our law offices immediately for a free and confidential case  evaluation.

Sources:

1. Guidant  Initiates Worldwide  Physician Communications Regarding Important   Safety  Information and  Corrective Action about Implantable Cardiac Defibrillators from www.fda.gov accessed 06/27/05.
2. Urgent Medical Device Safety Information & Corrective Action from Guidant Corp. Issued June 23, 2005, accessed on 06/27/05.
3. WebMD’s Guide to Heart Disease from www.webmd.com accessed on 06/27/05.
4. Preparing for Heart Failure Device Therapy accessed on 06/27/05.
5. Doctors Shouldn’t Use Defibrillator Models, www.forbes.com (The Associated Press article) accessed on 06/27/05.
6. Guidant Tells Doctors Not to Use Five Defibrillators from www.theindychannel.com accessed on 06/27/05.
7. FDA  Issues Nationwide Notification of Recall of Certain Guidant  Implantable  Defibrillators and Cardiac Resynchronization Therapy  Defibrillators, June 17, 2005. www.fda.gov accessed on 06/27/05.

This  article is for informational purposes only. It is not intended to  constitute medical advice and should not be viewed as such. For medical  advice you should always consult with your physician.

AVT®,  CONTAK®, CONTAK RENEWAL®, VENTAK®, VENTAK PRIZM and VITALITY® are  registered trademarks of Guidant Cardiac Rhythm Management (doing   business as Cardiac Pacemakers, Inc.).

This law firm is not  associated with, sponsored by or affiliated with Boston Scientific,  Cardiac Pacemakers, Inc., Guidant Corp., Guidant Rhythm Management, the  FDA, Forbes, the Indy Channel or WebMD.

Defective Medtronic Device

Medtronic,  Inc., a Minneapolis-based self-proclaimed leader in medical  technology,  pain   alleviating, health restoration, and life extension  for millions  of people around the world alerted physicians in February  of 2005 that  some of their implantable heart devices are subject to  differing  battery failures, effectively negating the device.

Ironically,  in 2005, Guidant Corporation recalled over 50,000 of its implantable   heart devices due do a  failure to deliver a shock when needed, posing  serious cardiovascular risk to the patient.

Medtronic Device Failure

On  February 11, 2005, the FDA reported, “Medtronic, Inc., (NYSE: MDT)  today said it is voluntarily advising  physicians about a potential    battery shorting mechanism that may occur  in a subset of implantable   cardioverter-defibrillator (ICD) and cardiac resynchronization therapy  defibrillator (CRT-D) models. In a letter to physicians, Medtronic  reported that nine batteries have experienced rapid battery depletion  due to this shorting action. If shorting occurs, battery depletion can  take place within a  few hours to a few days, after which there is loss  of device function (1).”

Affected Devices:

Implantable cardioverter-defibrillator models:

Marquis ® VR 7230
Marquis ® VR 7274
Maximo™ VR 7232
Maximo™ DR 7278

Cardiac resynchronization therapy defibrillators:

InSync ® I Marquis ®
InSync ® II Marquis ®
InSync ® III Marquis ®
InSync ® III Protect 7277
InSync ® III Protect 7289

What should I do if I received on these devices?

Always  consult with your physician for medical advice. If you received one of   these devices and are concerned about the possible health risks,  contact our law offices immediately for a free and confidential case  evaluation.

Sources:

1. “Medtronic Issues Notification Regarding Certain Implantable Defibrillator   Models” from www.fda.gov.
2. “WebMd’s Guide to Heart Disease” from www.webmd.com accessed on 06/27/05.
3. “Preparing for Heart Failure Device Therapy” accessed on 06/27/05.

This  article is for informational purposes only. It is not intended to  constitute medical advice and should not be viewed as such. For medical  advice you should always consult with your physician.

Marquis ® and InSync ® are registered trademarks of Medtronic, Inc. and are used here only to identify the products in question.

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