Guidant Corp. warned doctors Thursday of more problems with some of its pacemakers, saying at least 10 people have been hospitalized because of flaws in some essential functions. The alert involves Guidant’s Insignia and Nexus lines of pacemakers. The NY Times reported that Senator Charles Grassley, chairman of the Senate Finance Committee, notified Guidant that his committee is investigating where the company had violated a 2003 agreement that required it to notify the government of product problems. The FDA considers the pacemaker action to be a recall, making it the 5th recall by the company. The latest problems include intermittent or permanent loss of pacing output, loss of telemetry, and the appearance of a warning message when the device is being checked, a spokesman for Guidant said.

Medtronic, the nation’s biggest manufacturer of heart devices, has said that it was considering making available to doctors and patients some of the datat concerning product malfunctions that until now only provided to federal regulators. Currently, manufacturers of devices like defibrillators and pacemakers provide the FDA far more details about how and why those devices are malfunctioning than they currently give to doctors. Medtronic already provides more information to doctors than its two leading competitors, Guidant and St. Jude Medical.

The FDA is expected to release a new study showing that implantable heart defibrillators have been malfunctioning at an increasing rate. The study found that defibrillator malfunctions were directly responsible for 61 confirmed deaths. This study will be released in light of the controversy over how the Guidant Corporation disclosed problems with some defibrillators.

The Wall St. Journal is reporting that Guidant Corporation admitted Friday that one of the recommendations it made to physicians in June may make make the pacemaker problems worse and increase the risk to patients. Last month, Guidant issued safety warnings on 11 of its models affecting about 88,000 people.

An FDA evaluation of the five Guidant defibrillators pulled from the market last month will take weeks not months. Guidant pulled the five defibrillators off the market after safety concerns arose. Daniel Schultz, director of the Center for Devices and Radiological Health, said it is up to patients and doctors to determine a course of action in cases where the devices have already been implanted in patients. Some of the deviced affected have been designated “Class I” by the FDA, meaning they have the highest priority recall, while others have been given a “Class II” designation. Class I means that there is a reasonable probability that the malfunctioning device could cause death or major adverse health consequences. The devices given Class I designation are Guidant’s Ventak Prizm 2 DR and Guidant’s Contak Renewal 1 and 2 devices. In other words three of the five Guidant defibrillators have a reasonable probability to cause death or very serious health problems.

The recent news that Guidant defibrillators may malfunction during life critical moments has given heart patients pause. The highest rate of malfunction among Guidant machines is the Ventak Prizm 2 DR (Model 1861)with 28 reports of short-circuiting including one resulting in death. According to a story in today’s Wall St. Journal, physician reaction is mixed. The WSJ reported that prominent Indiana cardiologist Douglas Zipes believes it’s a matter of conscience. “I put the implanted defibrillator in the patient because the patient is at risk of sudden death. How can I in good conscience then not replace the device?” At this point, it’s important to check with your cardiologist if you have one of these implanted devices. Also, keep monitoring my blog for the latest updates.

According to a June 14th article in the NY Times, heart device manufacturers make their own decision when and if to inform the general public and doctors if a potentially life saving heart device like a defribrillator is faulty. There are no set guidelines and there is no close monitoring of these devise manufacturers even though they make outrageous profits. The article points out the recent death of a 21 year old student with an implanted defibrillator made by the Guidant Corporation. Unfortunately, patient safety is not the only concern of these companies. The potential loss of profits as well as the legal liability play huge roles in the company’s evaluation of the benefits of disclosing a product flaw. Until there is closer monitoring, consumers are not safe.

Guidant Corporation is recalling 29,000 heart devices because of flaws that may cause them to malfunction when they are supposed to deliver a potentially life saving electrical shock to the heart. The three defibrillator devices manufactured by Guidant came under FDA scrutiny during their review of Guidant’s handling of issues surrounding the three products particularly the Prizm 2 DR. The other two models are the Contak Renewal and the Contak Renewal 2. Guidant did not tell doctors for more than three years that the product (Prizm 2 DR) was prone to electrical failure due to a design flaw. Guidant also disclosed yesterday that the other two products were prone to the same failure. The company said it was aware of two recent deaths involving the units at issue.