Software Update to Detect Medtronic Lead Fractures
Last Week the FDA approved a new software update which is supposed to help doctors monitor their defibrillator patients for potential Medtronic lead fractures. The update is designed to benefit over 235,000 people who received a Medtronic Sprint Fidelis lead, which was recalled on October 15, 2007.
>>INFORMATION: Medtronic Lead Recall
The Medtronic recall was issued because the Sprint Fidelis lead was found to have an increased risk of fractures or breaks, which could result in unnecessary shocks or cause their defibrillator not to work if it is needed to provide life-saving treatment.
Given the considerable risk involved in attempting to remove a Medtronic defibrillator lead or implant a new lead, experts have recommended that the leads not be extracted unless there is evidence of a fracture. At the time of the recall, doctors were told to reprogram their patient’s ICDs so that they could better detect when something went wrong, and patients were reassured that this would minimize the risk of injury or harm if the lead fractures.
However, a study published in February 2008 on a website for the Heart Rhythm Society, indicated the enhanced monitoring was relatively ineffective in preventing Medtronic lead problems and adverse health events. Of 514 Sprint Fidelis leads implanted at the Minneapolis Heart Institute, data indicated that 17 failed between 11 and 35 months after insertion. Although the defibrillators had been reprogrammed, researchers found that 12 of these patients received inappropriate shocks and two did not hear the warning alarms.
The latest software update is designed to help doctors improve their chances of identifying a potential fracture earlier. However, it still will not help reduce the risk of a fracture, and it will not help doctors repair a fracture if one does develop.
Even if the software does allow doctors to better detect the fracture before the patient experiences an unnecessary shock or failure of their defibrillator, they will still face a risky procedure to attempt to extract the lead or implant a new one. These procedures carry a risk of infection, damage to the heart valve, the possibility that the lead may puncture or perforate the heart or damage the vein.
MEDTRONIC LEAD RECALL LAWSUITS
It has been nearly a year since the Medtronic defibrillator lead recall was issued for the Sprint Fidelis wires. Thousands of people have been living in fear that their leads may fracture and they have been receiving additional medical monitoring to watch for signs of a fracture. These problems could have been avoided if Medtronic had done a better job of designing, manufacturing and testing their product.
The Medtronic lead lawyers at Saiontz, Kirk & Miles, P.A. represent individuals who received the Sprint Fidelis lead, regardless of whether they have yet to experience Medtronic lead problems. A number of legal hurdles are being faced, but our lawyers remain committed to pursuing all of the legal options available to our clients.
Potential Medtronic lead recall lawsuits are still being reviewed for individuals who do not have legal representation. If you, a friend or family member received a Medtronic Sprint Fidelis lead to connect your cardiac defibrillator to the heart, request a free consultation and claim evaluation.
