Medtronic recall issued due to defibrillator lead problems raises questions for many
Over 235,000 people have been exposed to the risk of serious and potentially fatal injury as a result of a defective defibrillator lead which was sold by Medtronic, Inc. The Sprint Fidelis lead was recalled on October 15, 2007 after data confirmed that it was prone to fractures which could cause the device to fail or result in unnecessary electrical shocks. Many individuals who have one of the recalled leads now question why the Sprint Fidelis was used instead of an older, thicker wire. In addition, many are questioning whether they ever should have received a defibrillator to treat their heart condition.
>>INFORMATION: 2007 Medtronic recall
The Medtronics Sprint Fidelis lead is a small electrical wire used with implantable cardiac defibrillators, also known as ICD or CRT-D. The wire connects to the heart muscle to monitor the beat and deliver a life saving electrical charge if an abnormal heart rhythm is detected.
When it was introduced in September 2004, the Sprint Fidelis lead was the smallest defibrillator wire available, replacing the Sprint Quattro which was introduced in 2001. Medtornic, Inc. is a global leader in heart devices and they heavily promoted the thin wire to gain a competitive advantage over other cardiac device companies. As a result, many doctors elected to use the Sprint Fidelis lead.
While the smaller lead does make for easier insertion, there are no established long term benefits of a smaller wire. After the Sprint Fidelis lead was placed on the market, Medtronic received reports of defibrillator problems where individuals suffered unnecessary shocks or the device failed to properly function when it was needed to deliver a life-saving treatment. Despite evidence of problems with their lead, they delayed issuing the recall, exposing thousands to an unnecessary risk.
>>PRIOR POST (11/1/2007): Medtronic recall could have come earlier
In the wake of this recall, many have questioned the widespread use of defibrillators in the United States and whether the devices were the best treatment option for many who have one of Medtronics leads. While the devices are credited with saving lives every year, some doctors choose to treat patients with medications instead of an implanted defibrillator. Data has suggested that as many as 80% of the individuals who receive a defibrillator never need the life-saving electrical charge.
Sales of the heart devices to Americans in 2006 accounted for more than $4 billion of the $5.6 billion global market for defibrillators. This was partially due to heavy marketing campaigns designed to convince doctors that their patients should be referred for one of the devices. Medtronic even ran a brief advertising campaign which was directed to patients, as opposed to doctors.
MEDTRONIC DEFIBRILLATOR LEAD RECALL LAWYERS
The lawyers at Saiontz, Kirk & Miles, P.A. represent individuals who have had one of the Sprint Fidelis defibrillator leads implanted (model numbers 6930, 6931, 6948, 6949). Medtronic recall lawsuits are being reviewed regardless of whether defibrillator problems have been caused by the defective leads. If you, a friend or family member believe you may have one of these leads, request a free consultation.
