Posts for the 'Medtronic' Category
Medtronic lead recall information video
The December 2007 FDA Patient Safety News show contains a segment highlighting the Medtronic lead recall, which has impacted 235,000 people with one of the defective wires connecting their defibrillator to the heart. The lawyers at Saiontz & Kirk, are reviewing Medtronic lead recall lawsuits nationwide for any individuals who have one of the recalled leads, which will be indicated on patient information card with any of the following model numbers: 6930, 6931, 6948 or 6949.
>>MORE INFORMATION: Medtronic lead recall
Medtronic investigations initiated by federal government
Medtronic, Inc. has acknowledged that they are the subject of multiple federal investigations regarding their marketing practices and the recent Sprint Fidelis defibrillator lead recall. The Senate Finance Committee and the Justice Department have both asked the company for information as part of investigations of wrongdoing. They also face thousands of potential lawsuits from individuals who received one of the defective wires, which are used to connect implantable defibrillators to the heart.
Thousands may face tough decisions if their Medtronic Defibrillator wire fails
Approximately 235,000 individuals have one of the recently recalled Medtronic defibrillator wires implanted in their chest. According to initial estimates, about 4,000 to 5,000 people could have their lead fracture or break. However, experts are not recommending that doctors replace Medtronic defibrillator leads which have been recalled, as the risks associated with attempting to remove the lead from the vein that carries it to the heart could outweigh the risk of a lead failure.
>>INFORMATION: Medtronic Defibrillator Wire Recall
Medtronic wire recall causes drop in company revenue as lawsuits mount
Medtronic, Inc. announced a significant drop in sales for their defibrillator business during the third quarter following the recent Sprint Fidelis recall. The company estimates that they have already lost about $130 million in sales as a result of the Medtronic wire recall, and they also face thousands of potential lawsuits from individuals who had one of the defective leads used to connect a defibrillator to their heart.
>>INFORMATION: Medtronic wire recall
St. Jude defibrillator leads could puncture a hole in heart
Last month, Medtronic issued a recall for their Sprint Fidelis defibrillator lead after it was discovered that the lead was prone to fractures. Yesterday reports were released which indicate that other defibrillator leads made by St. Jude Medical, Inc., could contain a design flaw which makes it more likely to puncture a hole in the heart.
Medtronic lead recall applies to defibrillators since 2004, not pacemakers
Following the recent Medtronic lead recall, many individuals with implantable devices have questioned whether they have the potentially dangerous wires. The recall applies to all models of Medtronic Sprint Fidelis leads, which could have been used with any defibrillator implanted since 2004. However, the leads are not used with any types of pacemakers.
>>PRIOR POST (10/18/2007): Medtronic Sprint Fidelis Recall Read the rest of this entry »
Medtronic lead recall could have come earlier
Since the October 15th Medtronic recall for all models of their Sprint Fidelis defibrillator lead, more information has come to light about what Medtronic knew and when they knew it. Despite information which was presented to company executives, Medtronic delayed the defibrillator lead recall for several months, allowing doctors to continue implanting the defective wires.
>>INFORMATION: Medtronic Lead Recall
Congress questions FDA about Medtronic recall
One week after a Medtronic Defibrillator Lead recall was issued, the U.S. Congressional Committee on Oversight and Government Reform wants to know what the FDA knew and when they knew it. Approximately 235,000 people have the defective lead implanted with their cardiac defibrillator, and many now question whether the FDA and Medtronic could have prevented thousands of potentially fatal problems
>>INFORMATION: Medtronic Recall
Risk of Medtronic defibrillator lead malfunction may be higher for children and young adults
Last week, Medtronic recalled their Sprint Fidelis defibrillator lead after it was discovered that the small electrical wire is prone to fracturing or breaking, which could result in serious injury or death. Medtronic data Initially suggested that the overall failure rate was about 2.3% at 30 months, which means 4,000 to 5,000 people could experience problems. However, new research indicates that the malfunction rate may be substantially higher for children and young adults who received the defibrillator lead wire.
>>INFORMATION: Medtronic Defibrillator Lead Malfunctions
Medtronic Sprint Fidelis recall: Defibrillator lead could fracture
Medtronic, a global manufacturer of heart devices, suspended sales of their Sprint Fidelis defibrillator lead wire this week. The leads could be a part of any defibrillator system implanted since 2004. Defects could cause the wire to fracture or break, resulting in a severe shock or preventing the device from working when it is needed.
>>INFORMATION: Medtronic Sprint Fidelis Recall Lawsuits
