Medtronic Faces Lawsuits Over Recalled Sprint Fidelis Defibrillaor Lead
Date Published: Wednesday, January 4th, 2012
The Medtronic Sprint Fidelis defibrillator lead that was recalled by its manufacturer five years ago could deliver random shocks to the heart, a Canadian class-action lawsuit alleges.
In 2007, Minneapolis-based Medtronic Inc. issued a global recall of the special wires that link a patient’s heart with a defibrillator implanted in the body.
Medtronic said at the time that it was stopping distribution of its pacemaker defibrillator wires for a fracture problem that may have be linked to five patient deaths and health difficulties.
Based on initial reviews of reported adverse events, some deaths and major complications have occurred after the leads fractures. At time of the recall more than 268,000 leads were in use including about 6,000 in Canada.
At least five people with the devices died prior to the recall of the leads. Since then, as many as 20 more deaths have occurred, according to CBC News. Studies suggest the failure rate of the leads increases over time.
Dr. Jamil Bashir, a cardiac surgeon at St. Paul’s Hospital in Vancouver who implanted the defibrillators in patients, told CBC News that doctors at the hospital have removed more than 100 of the leads.
Sherry Robinson of Sechelt, B.C., is one of the plaintiffs filing suit against Medtronic. She claims she experienced a series of violent shocks before her leads were removed.
Robinson joined a class action lawsuit against the company, which covers more than 6,300 Canadians and their families who were implanted with the defective leads, whether or not they’re having problems with the devices.
The case is unlikely to be decided soon. An Ontario judge originally approved the case as a class action in 2009, but it could take a year or more before lawyers argue it in court.
This entry was posted on Wednesday, January 4th, 2012 at 6:36 pm and is filed under Uncategorized.
Medtronic Faces Lawsuits Over Recalled Sprint Fidelis Defibrillaor Lead
Date Published: Wednesday, January 4th, 2012
The Medtronic Sprint Fidelis defibrillator lead that was recalled by its manufacturer five years ago could deliver random shocks to the heart, a Canadian class-action lawsuit alleges.
In 2007, Minneapolis-based Medtronic Inc. issued a global recall of the special wires that link a patient’s heart with a defibrillator implanted in the body.
Medtronic said at the time that it was stopping distribution of its pacemaker defibrillator wires for a fracture problem that may have be linked to five patient deaths and health difficulties.
Based on initial reviews of reported adverse events, some deaths and major complications have occurred after the leads fractures. At time of the recall more than 268,000 leads were in use including about 6,000 in Canada.
At least five people with the devices died prior to the recall of the leads. Since then, as many as 20 more deaths have occurred, according to CBC News. Studies suggest the failure rate of the leads increases over time.
Dr. Jamil Bashir, a cardiac surgeon at St. Paul’s Hospital in Vancouver who implanted the defibrillators in patients, told CBC News that doctors at the hospital have removed more than 100 of the leads.
Sherry Robinson of Sechelt, B.C., is one of the plaintiffs filing suit against Medtronic. She claims she experienced a series of violent shocks before her leads were removed.
Robinson joined a class action lawsuit against the company, which covers more than 6,300 Canadians and their families who were implanted with the defective leads, whether or not they’re having problems with the devices.
The case is unlikely to be decided soon. An Ontario judge originally approved the case as a class action in 2009, but it could take a year or more before lawyers argue it in court.
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