Posts for the 'Medtronic' Category
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
UPDATE: Medtronic Concerto heart device approval re-affirmed by FDA
On January 31, 2007 we posted information regarding allegations of problems with the Medtronic Concerto heart device. Read the rest of this entry »
Medtronic Concerto heart device problems identified by whistleblower
A former engineer at Medtronic has openly criticized the medical device manufacturer, claiming that they failed to adequately test their new Concerto implantable heart device. Approximately 11,000 of these heart devices have already been implanted in the United States, which raises serious concerns about any potential problems with the device. Read the rest of this entry »
