A Guidant Corporationconsultant told the medical device company that it had an ethical obligation to inform doctors of defects in its defibrillator device. Dr. Richard N. Fogoros, also told company executives that their decision to withhold such data, while statistically defensible, was questionable. In one of two lengthy memos to Guidant executives, Fogoros wrote that the company violated a...
According to an article in the NY Times, "A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday.The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for...
30 common but preventable medical mistakes: 1. Prescribing the wrong dosage of medication 2. Prescribing the wrong medication 3. Providing medications not prescribed 4. ...
Thankfully for the sick in Minnesota, a surgeon will stop seeing patients after he removed the wrong kidney from a patient. In doing so, the surgeon left a cancerous kidney inside the patient. The surgery was done last Tuesday, but only on Wednesday was it discovered what had happened. To prevent something like this from happening again, the Chief Medical Officer of the hospital said that...
California has closed its confidential program that allowed physicians to continue to practice medicine while undergoing treatment for alcohol and drug abuse. There have been many cases of medical malpractice, even those involving injury and death, committed by physicians in treatment programs administered by state medical boards. Many physicians successfully recover while under such programs...
In recent years we have heard certain lawmakers rail against evil trial lawyers and advocate for bans or strict caps on medical malpractice cases. Now, one of the leading lawmakers for "tort reform" has, so to speak, gotten a taste of his own medicine. According to an article in the Jacksonville Times-Union: It has been a staple of Stephen Wise's political career. As a state representative and...
The FDA is recalling the MRL/Welch Allyn AED 20 Automatic External Defibrillator that is used by emergency personnel in hospitals, at fire stations and other risk management departments to treat heart attack victims. The defective equipment may show an error message (Defib Comm) which can result in the medical personnel giving improper treatment. Hospitals, fire departments, and ambulance...
According to a report published in the NY Times, Guidant Corporation has issued a warning to doctors about possible battery defects in two of its implantable defibrillator devices. The devices in question, the Contak Renewal 3 RF and Renewal 4 RF cardiac defibrillators, have not been implanted in any patients thus far. Guidant said the FDA may classify the warning as a product recall.
New limits imposed by the FDA on Guidant, maker of an implantable heart defibrillator found to be defective, will make it difficult for new products made by the company to be approved for commercial sale, as the agency applies pressure to the company to improve its manufacturing procedures. In the letter, sent a week ago, the agency said Guidant had not fully responded to its concerns about...
Guidant's chief executive will receive a $1.5 million bonus after the acquisition by Boston Scientific is complete, according to documents filed with the U.S. Securities and Exchange Commission. Since June, Guidant has recalled or issued safety advisories on about 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices. I guess that...
Showing items 61 to 70 of 76
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