Guidant Heart Devices

posted on:
May 17, 2007

author:
Staff

What is a Guidant heart device?

Mechanical implantable heart device such as pacemaker or defibrillators known to significantly improve survival and the quality of life of patients.

What are the dangers associated with Guidant heart devices?

On June 17, 2005, the Food and Drug Administration (FDA) reported that Guidant Corporation had recalled nearly 50,000 implantable defibrillators and cardiac resynchronization defibrillators because of defects that could lead to serious injury and/or death. These models affected are:

  • Contak Renewal
  • Contak Renewal 2
  • Ventak Prizm 2DR
  • Ventak Prizm AVT
  • Vitality AVT

Less than one week later, Guidant issued a second safety advisory affecting the additional ICD’s:

  • Contak Renewal 3 & 4
  • Renewal RF
  • Renewal 3 & 4 AVT.

On June 24, 2005, Guidant Corp. issued a second safety advisory to warn doctors that many of its devices may malfunction. The U.S. Food and Drug Administration (FDA) notified health care providers and patients that a seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

The following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.

PULSAR® MAX Models 1170, 1171, 1270
PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
MERIDIAN® Models 0476, 0976, 1176, 1276
PULSAR MAX II Models 1180, 1181, 1280
DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
CONTAK TR® Model 1241
VIRTUS PLUS® II* Models 1380, 1480
INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
VIRTUS PLUS II and INTELIS II models available only outside the U.S.

As of July 11, 2005, Guidant had received reports that 69 pacemakers may have failed because of the leakage. Twenty of the devices were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients.

Guidant also received reports of two patients who had sustained pacing at a rapid rate. A patient whose device exhibited sustained pacing at a rapid rate was admitted to the hospital and later died. The device problem could not be confirmed as leakage since the device was not returned.

Guidant announced the initiation of a voluntary recall on July 18, 2005. The recall action consisted of a letter to physicians that describes the problem and provides recommendations about how to minimize the risk of pacemaker failure.

On, September 22, 2005, Guidant Corporation sent letters to physicians containing safety information regarding the Guidant models INSIGNIA** and NEXUS** implantable heart pacemakers. One or more of the following device behaviors may be observed: (1) Intermittent or permanent loss of pacing output without warning; (2) Intermittent or permanent loss of telemetry; and (3) Reversion to VVI mode or appearance of a reset warning message upon interrogation.

On June 26, 2006, 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.

Boston Scientific recommends 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.

In July 2006, the FDA met with Guidant to discuss the firm’s announcement that several models of pacemakers and implantable defibrillators should be removed from hospital inventories because they have the potential to malfunction due to failure of the capacitor. The capacitor controls how the device holds its power supply. The FDA fully supports Guidant’s recommendation that physicians perform follow-up exams of patients with devices that may be susceptible to this malfunction.

Guidant’s problems may include intermittent or permanent loss of therapy, premature battery depletion, or other malfunctions. The FDA is closely monitoring the situation and met with Guidant to discuss their plans to investigation the problem, inform physicians, and resolve the problem as quickly as possible.

Approximately 18,000 of the affected devices remain in service in the United States and an additional 10,000 are in service in other countries. Guidant estimates that the failure rate from the leakage defect will be between 0.17 percent and 0.51 percent (i.e., between 1.7 per one thousand and 5.1 per one thousand) over the remaining lifetime of the devices. It is possible that the actual failure rate will be greater than this, in part, because some past failures may not have been reported to Guidant.

What can I do if I have been injured by a Guidant heart device?

If you or a loved one are the recipient of an implanted Guidant defibrillator or pacemaker and have suffered a serious side effect as the result of using this device, you may be entitled to compensation. For a free legal consultation, contact us today!

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