Guidant Implanted Defibrillators NewsFREE Case Review
Boston Scientific/Guidant and the FDA recalled a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families
Boston Scientific/Guidant and the FDA recalled a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families. This new recall includes about 73,000 implantable cardiac resynchronization therapy defibrillators and cardiac defibrillators due to faulty capacitors. While this recall is similar to the recall of May 2006, this time the failure modes and patient outcomes differ. The capacitors have been causing accelerated battery depletion and reducing the time between the elective replacement indicators and end of life to less than three months.
27,200 Guidant pacemakers and defibrillators recalled due to fault electronic part
The troubles for Indiana-based Guidant Corporation continue to mount. On June 26, 2006, Guidant’s parent company Boston Scientific elected to recall six models of defibrillators and pacemakers because an electrical flaw can cause the units to malfunction. The problem lies in the low-voltage capacitors which store electrical charges for the units that enables them to function properly. Defective capacitors can rapidly drain a battery, rendering the units worthless.
Although Guidant did not explicitly state the number of devices the affected by this recall, 27,200 potentially defective devices have already been implanted in patients across the country. The affected units include:
- Insignia pacemakers
- Nexus pacemakers
- Contak Renewal TR/TR2 cardiac resynchronization pacemakers
- Ventak Prizm 2 cardioverter defibrillator
- Vitality cardioverter defibrillator
- Vitality 2 cardioverter defibrillator
In the five units that experienced the malfunctioning capacitors, two people became unconscious when their devices failed to work properly. Four patients needed surgery to replace the units, and the defect was discovered during the implantation procedure in another patient.
This recall on June 26, 2006 follows recent allegations that Guidant withheld important information about the quality of their products. In the past few years, Guidant recalled hundreds of thousands of defibrillators and pacemakers due to a variety of defects.
Guidant Accused of Sabotaging Effort to Warn Consumers About Malfunction
Another controversy has dealt a blow to Guidant Corporation as new allegations claim that the organization withheld a letter that could have provided early warning to doctors and patients about potentially fatal malfunctions in many of their popular cardiac defibrillators. Rather than face the responsibility of admitting their mistakes, Guidant instead chose to release a routine “product update” about the potential problems with their devices.
The choice to withhold this vital information could not have come at a worse time for Guidant, which is already facing a huge backlash due to the failures and malfunctions in tens of thousands of defibrillators and pacemakers. Seven people are reported to have died due to complications from these defective devices, but the courts have yet to determine if the withheld letter impacted these fatalities in any way.
The letter was uncovered over protest and objection of Guidant, and it revealed that the company knew that “certain cardiac resynchronization therapy defibrillators” had a “rare performance issue”, but then later determined that there was no evidence of a trend that could adversely affect patients. The company even dated the letter “January XX, 2005”, and addressed it to anonymous “Doctor XXX”, obviously indicating that there was enough precedent to warn patients and doctors of a real and present danger.
Judge Jack Hunter ruled that Guidant tried to cover their tracks by marking an additional 600,000 pages of documents as confidential, thereby reducing the likelihood of them being used as evidence. The company has until Wednesday, June 7 to decide what other documents may have been “improperly” marked as confidential.
Woes continue to mount for embattled medical technology manufacturer Guidant Corporation, as the company announced yet another recall on January 24, 2006 regarding 19,300 pacemakers. According to sources at the company, a seal on some of these older devices may leak which can disrupt the delicate electronics that help regulate heart rate.
This newest report comes at an inopportune time for Guidant, the company the subject of a bidding war between rival companies Johnson & Johnson and Boston Scientific, as this recall comes close on the heels of multiple recent recalls and advisories of over 100,000 Guidant brand pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices in 2005.
The recall of these older units reinforces the accusations of substandard manufacturing oversight in precision medical devices that have plagued Guidant for the last year. This new recall could jeopardize the price tag Guidant seeks, which now floats around $63 a share, for a total of $27 billion.
The latest figures released by the company indicate that there have been 145 “incidents” related to the seal problem, but according to Guidant, the leaky seal of the pacemakers in question present "serious health consequences" for the patients who rely on them for their very lives. Guidant also urged patients with these devices to contact their doctors in order to determine the best course of medical action.
Plagued by a series of dangerous mishaps and numerous dramatic recalls of large numbers of defective cardiac equipment, Guidant Corporation has come under fire again recently for new allegations of reduced quality control procedures. Former employees are questioning the manufacturer’s loyalty and charging that the medical device maker put the drive to increase profits ahead of consumer safety.
The company is accused of emphasizing production speed over quality, according to a worker in the troubled factory. Management set ``unrealistic'' goals for production of pacemakers and defibrillators and offered incentives for meeting them that included cash bonuses and Minnesota Vikings football tickets, said Juan A. Machado, a worker of 14 years who trained others there and who spoke under oath during a Texas product liability suit against the Guidant.
At issue is the reliability of Guidant’s Implantable Cardiac Defibrillators and Pacemakers. These devices are about the size of a deck of cards and implanted in the upper chest. Depending on the model, these machines regulate heartbeat through electrical stimulation to prevent heart attacks or cardiac arrest.
Guidant recalled over 100,000 faulty cardiac devices in June 2005 due to potentially serious defects that allegedly led to seven deaths. As of January 2006 there have been 60 individual lawsuits filled on behalf of clients who were adversely affected by Guidant’s lack of quality oversight.
Quality control became such an issue that the Food and Drug Administration issued a warning letter to Guidant on Dec. 22 that stated such irresponsibility to the public “may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems.'' In order to protect the public the FDA will not allow Guidant to export or pre-market some defibrillators and pacemakers until at least the middle of 2006.
John Mallow, a former FDA investigator and regulatory compliance consultant, summed up the case against Guidant by saying “Cash incentives for increasing volume is absolutely a bad idea. Do you want the pacemaker made by the guy who made it the fastest or the one who made it the best?''
His thoughts were echoed by Jeanne Lesniak, a biomedical engineer and consultant for the FDA for compliance and quality issues. According to her, bonuses to increase output in medical device assembly areas are “unheard of.” Workers without adequate training forced to assemble precision medical devices is without doubt a recipe for disaster.
Thousands of patients now must live with the anxiety that their potentially life-saving device will fail when they need them most. Severe mental anguish and constant fear are some common claims sited in the lawsuits pending against Guidant.
New studies have developed regarding more patient deaths associated with defective heart devices manufactured by Guidant Corporation. Guidant has reportedly notified the FDA of 3 new deaths due to complications from the heart devices. In June, Guidant was forced to recall these devices after instances of short circuiting emerged. Currently there have been a total of 7 deaths associated with this flaw.
This current development is another example of problems that have plagued Guidant since 2002. Since then, the company has recalled over 200,000 pacemakers due to malfunctions and has issued warnings in (or recalled) 88,000 heart defibrillators. The U.S. Justice Department subpoenaed Guidant in October of 2005, as part of an investigation regarding the company’s handling of safety issues.
Defibrillators are medical devices that are used to sense and interrupt irregular heart rhythms while pacemakers are used to electrically stimulate the heart to regulate the heartbeat. In a statement, Guidant expressed that there are now five patient deaths associated with short circuits involved in the models Contak Renewal and Contak Renewal 2. There have been two deaths associated with the Prizm 2 DR model. Patients using the affected models are encouraged to consult with their doctors for medical guidance.