St. Jude Faces Second Recall

February 13, 2013

859734_back.jpgProduct recall lawyers at Pintas & Mullins report that St. Jude Medical voluntarily recalled its Eon and Eon Mini implantable pulse generators due to problems with the rechargeable battery. This is the second serious recall St. Jude has faced in two years, the first involving defects with the Riata Lead defibrillator medical devices.

The Eon recall covers nearly 35,000 devices manufactured before 2010. Implantable pulse generators are intended to treat chronic back pain by providing stimulation into the spinal area. The devices require recharging every 24 hours. The company initially realized the defects after more than 80 Eon Mini patients reported of the device failing to recharge. This may lead to loss of communication ability, which results in loss of pain relief and ultimately requiring an explant surgery.

Explant surgery presents a serious risk to patient health, just as any surgery involving the spine. Possible side effects associated with an unplanned explant surgery include scarring, pain, and infection, along with complications from anesthesia.

In some cases, the battery has severely burned the patient internally while recharging. In the defective batteries, amount of time between recharges become increasingly shorter until it either fails to charge completely, or suddenly looses functioning. St. Jude conducted an investigation into the root cause of these malfunctions, and determined that the defects are caused by weld failures within the internal battery, which caused them to crack, leak electrolytes, and rendered them unable to hold a charge.

Fortunately, the battery is hermetically sealed within the device, and will not leak electrolytes into the body. In the investigation, St. Jude reviewed its battery supplier's manufacturing process and determined that its process controls needed improvement.

By July 2012, there were more than 300 patient complaints of extreme warmth at the device site during charging. At this time, there were three reports of serious skin surface burns, one with a second-degree burn and two with first-degree burns. This is due to defects in the battery manufacturing as well as device design - the implants are often misaligned or located too near to the surface of the skin. The long-term rates of over-heating for these devices are not yet known.

St. Jude updated its product labeling in 2012, adding a supplement that addressed these issues with overheating and potential battery failure. The company also sent a letter to all physicians who implanted potentially affected devices, in which it detailed recommended steps for those patients experiencing uncomfortable warmth while charging.

St. Jude recommended that patients stop charging until the device cools down, reposition the charging antennae over the implant site, and consider recharging more frequently for a lesser amount of time. Patients should also avoid putting the charging wand between the body and a surface that may encapsulate warmth, like a bed or couch. It is also recommended that patients do not use a topical anesthetic, pain relief patches, or medicated balm on the implant site prior to recharging, as it may hinder the ability to feel excessive heat or burning. Finally, St. Jude recommends that patients do not recharge the device while sleeping, and do not consume alcohol immediately before or during a recharge.

As stated, these letters and reports were sent to Eon physicians, not the patients themselves. It is within standard practice for physicians to immediately notify all affected patients, however, as happened in at least one St. Jude Riata defibrillator case, this does not always occur. The child in this case was implanted with a Class I-recalled defibrillator for over two years before her parents realized the device was dangerously defective. Class I is the most severe FDA designation, reserved for products that can cause serious injury or death. Troublingly, today, there are still nearly 80,000 patients with the Riata devices still active internally.

Eon and Eon Mini device recall attorneys at Pintas & Mullins urge anyone experiencing excessive warmth or recharging defects to contact your physician immediately. Compensation may be available to those patients requiring explant surgery or who suffered other serious complications from the device defects.