Heart Lead Recall

posted on:
October 22, 2007

author:
Staff

What is a heart lead?

Manufactured by Medtronic, Sprint Fidelis leads are thin wires that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. Both devices work by monitoring heart rhythms and delivering an electrical shock to restore heart function when life-threatening heart rhythms occur. Mechanical implantable heart devices, such as pacemaker or defibrillator, are known to significantly improve survival and the quality of life of patients.

Fracture defects spur recall

On October 16, 2007, the FDA announced Medtronic had voluntarily suspended distribution of its Sprint Fidelis defibrillation leads because of fracture defect.

The following day, the FDA issued a Class I Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007.

Sprint Fidelis leads are thin wires that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. Both devices work by monitoring heart rhythms and delivering an electrical shock to restore heart function when life-threatening heart rhythms occur.

When a defibrillator lead is slightly more prone to fracture, most leads will function well, but in the circumstance where a lead actually breaks, or “fractures,” the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

The defibrillator leads pulled off the market by Medtronic Inc. may pose a higher risk of fracture in younger adults and children, a population for whom the devices were particularly popular in part because of their small diameter.

Children make up a relatively small share of patients who receive the implanted devices. But leads — wires that attach defibrillators to patients’ hearts — tend to come under greater stress in more-active people, including kids, adolescents and younger adults.

The company said that of the 268,000 Sprint Fidelis leads implanted, 2,085 were in patients under the age of 21. About 235,000 patients still have the leads, and the company said the fractures may have contributed to five deaths. The deceased patients’ ages haven’t been made public.

Preliminary data from physicians at 32 institutions who specialize in treating pediatric patients and adults with congenital heart disease showed a fracture rate of 6.7 percent among 569 patients with Sprint Fidelis leads over 30 months. The “vast majority” of the patients are likely to be under the age of 21, given the physicians involved, says Wayne H. Franklin, an associate professor at Northwestern University’s Feinberg School of Medicine, who gathered the physician reports.

Medtronic has reported a lower failure rate, 2.3 percent after 30 months, for all patients implanted with one particular Sprint Fidelis model. For that same model, Dr. Franklin saw a fracture rate of 4.9 percent among 304 patients in his survey. The real difference may be slightly greater, because the failure rate from Medtronic includes more than just fractures.

Patients who are implanted with this lead, or do not know the model of their lead, should contact their physicians for further information.

No more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company.

A recall was issued on February 10, 2005 for devices whose batteries were manufactured between April 2001 and December 2003. The devices included in this recall are the Marquis VR 7230, Marquis DR 7274, Maximo VR 7232, Maximo DR 7278, InSync Marquis 7277, InSync II Marquis 7289, InSync III Marquis 7279, and InSync III Protect 7285. According to Medtronic, Inc., none of the InSync III Protect devices were implanted in the United States.

On November 29, 2005, Medtronic, Inc., communicated to physicians, hospitals and regulatory authorities of potential problems affecting the Sigma® series pacemakers manufactured by Medtronic, Inc. They have determined that a potential separation of interconnect wires from the hybrid circuit may affect a small subset of the Sigma® series pacemakers. Approximately 28,000 Sigma pacemakers are subject to the advisory worldwide, of which approximately 6,650 are in the United States.

What can I do if I have been injured by a faulty heart lead?

If you or a loved one are the recipient of an implanted Medtronic defibrillator or pacemaker and have suffered a serious side effect as the result of using this device, you may be entitled to compensation. For a free legal consultation, contact us today!

 

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