Medtronic, Inc.’s October 2007 recall of its Sprint Fidelis defibrillator lead has caused many patients to panic over whether to replace their leads. However, there are two types of patients for which a fractured lead could mean an even higher risk of death.

Increased risk patients

According to a recent article in the New York Times, patients who have Medtronic’s Sprint Fidelis defibrillator leads (model numbers 6930, 6931, 6948 AND 6949) AND either 1) hypertrophic cardiomyopathy, or 2) a dual defibrillator/pacemaker unit may want to seriously consider having their leads replaced. Here’s why:

• Hypertrophic cardiomyopathy
  
  Hypertrophic cardiomyopathy (HCM) is a form of cardiomyopathy, a condition which causes the heart muscle to become thick, which makes it harder for the heart to work properly. When this happens, it can put additional stress on the Fidelis lead and cause it to fracture. So, HCM patients face a potentially greater risk of fracture due to their condition.
  
• Dual defibrillator / pacemaker units
  
  Patients with dual defibrillator / pacemaker units also potentially face a greater risk of fracture as the Fidelis lead is in essence, working overtime. Defibrillators are devices that monitor a heart’s rhythm and will send an electrical shock to the heart when the rhythm becomes abnormal. Pacemakers are devices which use electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart.
  
  So, a pacemaker maintains a person’s heartbeat, while a defibrillator restores a person’s heartbeat if it becomes abnormal. In order to do so, both devices must be connected to the heart. That is accomplished through a lead such as the Fidelis, which is a thin wire that connects the heart to the device(s).

Risk of fracture

Medtronic recalled its Sprint Fidelis lead after it received several reports that it may fracture. The company says that at least five deaths may have been linked to fractured leads, but industry experts say that number is probably higher. Approximately 235,000 patients worldwide are affected by the recall. While not all the leads have a risk of fracture, it has been reported that it is nearly impossible to tell which leads might be affected and when.

All patients with the Fidelis lead now have to deal with the risk of fracture – which means that if their heart “malfunctions” and their leads are fractured, they could suffer a serious heart condition – and possibly die. Unfortunately, patients with HCM or dual defibrillator / pacemaker units who use the Fidelis may be dealing with an even greater risk.

If you or a loved one has been injured as a result of this device, please contact an attorney who can evaluate your case right away. To contact a qualified attorney near you whose practice focuses in this area of law, please click here.