Defective Implanted Heart Devices Resource Center
Serious defects associated with various pacemakers & implantable cardiac defibrillators made by Guidant & Medtronic
In 2005, and in some instances earlier, the FDA became aware of serious defects associated with various pacemakers and implantable cardiac defibrillators (ICD) manufactured by Guidant and Medtronic. Since these early releases, both manufacturers have issued updates to the advisories or recalls previously issued and in some instances have identified additional devices which may also be subject to the previously identified defects.
The FDA is notifying health care providers and patients that the Guidant Corporation is recalling certain models of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.
The devices affected by this notification are:
- PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
- CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
- CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm. The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event for a patient. There have been two deaths reported to FDA suspected to be associated with this malfunction.
"FDA's first priority is patient safety," said Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health. "We want to ensure that all patients who may be affected by this problem are notified and seek appropriate medical advice from their physicians."
FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.
FDA advises patients to take the following steps:
- If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
- Continue to keep your regular doctor appointments.
- If you feel an electrical shock from your device, immediately contact your doctor.
- If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.
Guidant also recently informed FDA that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance. Currently, FDA is evaluating this information.
See your doctor if you have received a Guidant defibrillator device and you are concerned about your safety. In addition, it may be important to contact an Implanted Heart Device attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.
Guidant Suit Seeks Punitive Award
Guidant Corp. should be at risk of punitive damages for how it handled problems with implanted cardiac defibrillators that ultimately were recalled in 2005, attorneys for plaintiffs argued Friday during a court hearing in Minneapolis.
Guidant, which manufactured the devices in Arden Hills, was acquired last year by Boston Scientific. According to internal company documents presented during the hearing, Guidant knew of problems with its Prizm 2 devices nearly three years before it publicly disclosed them.
The company kept selling the device so it could keep pace with Fridley-based Medtronic Inc., its top competitor in the multibillion-dollar market, charged Nicholas Drakulich, an attorney for a California man who is one of more than 2,200 plaintiffs in lawsuits related to Guidant's controversial recalls.
Boston Scientific / Guidant Recall: Questions & Answers (April 10, 2007)
On April 5, Boston Scientific/Guidant recalled approximately 73,000 Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). A faulty capacitor in these devices can cause the batteries to deplete sooner than expected. Most patients will not be affected by this recall, but patients with one of the recalled devices should contact their physicians about what steps to take next.
In re: Medtronic, Inc. Implantable Defibrillator Product Liability Litigation
Pretrial Scheduling Order
Guidant Maker of Heart Device Kept Flaw from Doctors
A medical device maker, the Guidant Corporation, did not tell doctors or patients for three years that a unit implanted in an estimated 24,000 people that is designed to shock a faltering heart contains a flaw that has caused a small number of those units to short-circuit and malfunction.
Guidant Consultant Advised Company to Release Data on Defects
A consultant to the Guidant Corporation told the company last year that he believed it had a clear ethical obligation to tell physicians about heart device defects, and urged the company to overhaul its practices, newly released court records show.
F.D.A. Had Report of Short Circuit in Heart Devices
Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corporation heart devices, the agency received a report from the company showing that some of those units were short-circuiting, agency records obtained by The New York Times show.
F.D.A. Puts Restrictions on Guidant
The Food and Drug Administration yesterday released a warning letter it sent to the Guidant Corporation, restricting the ability of the company to win approval for some new medical products. In the letter, sent a week ago, the agency said Guidant, the heart device maker, had not fully responded to its concerns about manufacturing procedures at the company's biggest plant.
Implant Program For Heart Device Was a Sales Spur
By January, about 80 cardiologists nationwide completed an evaluation run by the Guidant Corporation of one of its products, an improved electrical component, known as a lead, that connects an implanted cardiac device to the heart.
Medtronic Advisory: Potential Premature Battery Depletion Due to Battery Short
Medtronic Marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 may experience rapid battery depletion due to a specific internal battery short mechanism. Battery design changes were implemented in December 2003 that eliminate the possibility of this internal shorting mechanism.