Tagged Articles

Administration 21 articles

Hamburg hopes to create a culture in FDA where concerns are heard

President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says if confirmed she would “create a culture (at the agency) that would enable all voices to be heard,” according to Thompson, a human resources Web site. The comment was made during a question-and-answer exchange with Sen. Barbara Mikulski (D-Md) during the 1 ½-hour confirmation hearing. Mikulski asked Dr. Hamburg if she would heed concerns made by whistleblowers, such as those made by a group of employees at the Center for Devices and Radiological Health that ... Read More

FDA meeting could compromise Medical Device Safety Act

The Food and Drug Administration (FDA) has planned an internal meeting today to discuss the strategic direction of the agency’s medical device center, adding fuel to concerns that the government agency carelessly approved medical devices and as a result put patients’ health and safety at risk, according to the American Association for Justice (AAJ). The meeting, which includes all scientists within the medical device evaluation office, is a rare gathering and likely to establish a plan for how the agency will handle a slurry of controversial issues including a Congress-initiated investigation of the device division by the Institute of Medicine, ... Read More

FDA issues Class I recall on ZOLL heart defibrillator

Another heart defibrillator has fallen under a Class I recall by the Food and Drug Administration (FDA). The recall on ZOLL AED Plus Defibrillators was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. The recalled devices were manufactured from May 2004 through February 2009 and distributed from May 2004 through February 9, 2009. The defibrillators that fall under the recall have serial numbers in which the last six numbers are under 200000. Defibrillators obtained prior to February 14, 2009 should have serial ... Read More

FDA to crack down on medical device manufacturers

The Food and Drug Administration (FDA) is cracking down on makers of medical devices that fall in the most risky category of products approved by the FDA, ordering the companies to provide tougher evidence of their products’ safety and effectiveness or pay for extensive clinical trials for their products currently on the market, according to the Wall Street Journal. The pressure from the FDA is long coming. In 1990, Congress ordered the more rigorous testing of medical devices before they became available for use, however the FDA never finished implementing the law, getting caught up in a federal loophole that ... Read More

Victim of defective defibrillator lobbies for Medical Device Safety Act

Ron Albrecht lives in fear – fear that one day he will learn that the defibrillator implanted in his chest is defective and will cause him excruciating pain when it fails, like his previous one did two years ago. That device turned out to be among the defective heart defibrillators that were recalled by the device’s manufacturer, Medtronic. Albrecht’s device had to be replaced, and while his new one appears to be operating fine, he still worries. “I don’t trust the unit itself,” he told NWI.com. “You’ve got that fear you’re constantly going to get shocked. It’s very traumatic.” Because ... Read More

Patients converge on Capital Hill for right to sue Medtronic

People with Medtronic cardiac defibrillators implanted in their chests converged on Washington, D.C., this week to lobby for the passage of the Medical Device Safety Act. The act will allow consumers who have been hurt by defective medical devices to sue the device’s maker even if the devices have been approved by the Food and Drug Administration (FDA). The bill was introduced by Democratic Reps. Frank Pallone Jr. of New Jersey and Henry Waxman of California after a Minnesota federal district court dismissed lawsuits filed against Medtronic by 1,496 individuals harmed by their malfunctioning Medtronic defibrillators. In 1997, Medtronic suspended ... Read More

Higher number of fatalities connected with Medtronic heart device

Medtronic Inc. has issued a letter to doctors stating that a defective lead wire in its popular heart defibrillator, which was recalled in October 2007, may have contributed to the deaths of 13 individuals in which the heart devices were implanted, according to the Star Tribune. That death toll is up from the medical device company’s original estimate two years ago of five deaths. In October 2007, Medtronic suspended the sale of many of its Sprint Fidelis Defibrillator leads after receiving reports of five fatalities connected with the devices. Fractures were found in devices which could cause them to unnecessarily ... Read More

Judge tosses medtronic lawsuits, doesn’t disclose son’s ties

U.S. District Judge Richard Kyle dismissed thousands of lawsuits against Medtronic Inc., manufacturer of the faulty Sprint Fidelis defibrillators that have allegedly injured and killed several people. Attorneys serving the patients, however, may seek to have the judge disqualified from the case because he never disclosed that his son works for the law firm representing Medtronic. Medtronic defended the Minnesota judge on Friday, saying that “this is clearly an effort to remove a well respected judge following rulings the plaintiffs’ lawyers do not like.” Richard H. Kyle, Jr., works for a Minneapolis based law firm with offices in the Midwest, ... Read More

FDA approves software update for faulty defibrillator

The U.S. Food and Drug Administration (FDA) approved a software update from Medtronic that will help detect fractures in the company’s Sprint Fidelis cardiac defibrillator lead. The software will alert both patients and physicians of a possible fracture in the defibrillator lead. Earlier intervention in the event of such a fracture will help patients avert the serious complications that can arise. The new software update, known as the Lead Integrity Alert, will sound an audible alert should it detect signals that indicate a fracture in the lead. The alert will sound repeatedly every four hours until a doctor can reset ... Read More

Poor FDA scrutiny of Medtronic Sprint Fidelis lead

The 2007 Medtronic Sprint Fidelis Defibrillator Lead Recall could just be the tip of the iceberg when it comes to defective implantable medical devices. That’s because the number of medical devices meant to be implanted in patients’ bodies is rapidly rising. Unfortunately, despite their rising numbers, as the case of the Sprint Fidelis Lead recall illustrates, the Food & Drug Administration (FDA) is doing a poor job of regulating implantable devices, and often ignores reports of device failures until someone dies. Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead ... Read More