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NEW PRODUCT FAILURE Reports say that over a million Americans are seriously injured every year by events that require medical gadgets. For instance, in 2002 alone, the U. S. Food and Drug Administration reported that there were 111, 000 instances of adverse events involving medical devices (U.
S. FDA Consumer Magazine, July-August 2003). A medical product that has recently been recalled in the market because it has been found to be defective is Guidant Corporations Cardiac Rhythm Management group which is presently a subsidiary of Boston Scientific. Approximately 22, 600 of a specific subset of pacemakers and defibrillators have now been recalled. Problem is, around 27, 200 of these devices are already implanted in patients.
Patients need to visit their doctors and check whether these devices are functioning properly (New Guidant Product Recall). The Boston Scientific and Guidant are both advising doctors to assess the condition of their patients. Even if the companies said that there may only be two to three additional devices out of this recall that may be defective. They are compelled to recall many more just to be sure (New Guidant Product Recall). Traced as to the cause of the defective products is the supplier of the defective capacitors. However, investigations into this will only be completed by the end of the year as demanded by the U.
S. FDA. What happened was that the implantable cardioverter defibrillators contained a defective low-voltage capacitor. These capacitors can lead to premature depletion of the battery or intermittent or permanent loss of therapy. This triggers an inappropriate sensing of heart rhythm. Some of these devices that were recalled are: Guidant INSIGNIA pacemakers Guidant NEXUS pacemakers Guidant CONTAK RENEWAL TR cardiac resynchronization pacemakers Guidant CONTAK RENEWAL TR 2 cardiac resynchronization pacemakers Guidant VITALITY implantable cardioverter defibrillators Guidant VENTAK PRIZM 2 implantable cardioverter defibrillators (New Guidant Product Recall).
In a similar scenario, a study presented at a meeting of the Heart Rhythm Society in New York has found that about one out of every five portable defibrillator units used in emergency situations have been the subject of either a safety alert or a product recall over the last ten years. This time, FDA records by researchers Dr. William H. Maisel and Dr.
Jignesh S. Shah of Beth Israel Deaconess Medical Center in Boston, found that a total of 164, 000 emergency defibrillator units have been recalled or been the subject of a safety alert. (1 of every 5 external defibrillators have failed). Recently, FDA analyzed some of the Guidant implantable defibrillators. A report was done on June 16, 2005 and indicated that the devices will experience defects leading to failures. This failures will be at a rate 10 times higher than that given by Guidant for the next five years.
It was a confidential document which involved a lawsuit which involved Guidant's products specifically in Texas (FDA expects higher rate of Guidant device failure). As if to aggravate the situation, the Guidant Corporation did not even mail notices about these defects in their heart devices. The court records reveal that Guidant drafted a letter that would inform doctors about these significant defects in their companys heart defibrillators. Yet no action was taken to actually mail it.
It was not mailed at all (Guidant Failed to mail Alerts About Defective Heart Devices). Guidant admitted that their Contak Renewal and Contak Renewal 2 had electrical defects. However they also acknowledged that all devices that were not in use were removed from the market (Guidant Failed to mail Alerts About Defective Heart Devices). Yet this was not enough to take the blame off the company.
Guidant now faces an investigation by the Department of Justice and the Food & Drug Administration because of this situation. WORKS CITED 1 of every 5 external defibrillators have failed. James Scott Farrin. Accessed 6 July 2006 at: web FDA expects higher rate of Guidant device failure. Boston Scientific device woes grow. Bloomberg News, June 23, 2006.
Guidant Failed to mail Alerts About Defective Heart Devices. June 2006. Edgar Snyder & Associates. Accessed 6 July 2006 at: web New Guidant Product Recall. James Scott Farrin Accessed 6 July 2006 at: web
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