Defibrillators are designed to deliver life-saving shocks to the hearts of patients with rapid, slow or irregular heartbeats. St. Jude Medical recalled several defibrillator models due to defective batteries that have caused patient deaths. Patients affected by the recall are advised to monitor their defibrillators closely.
A defibrillator is a medical device that delivers electric pulses to the heart when it is in distress. An irregular heartbeat can easily become deadly if left untreated. While most people are familiar with the defibrillators pictured in television and movie emergency rooms, also often called “crash carts,” scientific advances have allowed for miniature defibrillators to be developed.
An implantable cardioverter defibrillator, or ICD, is a small defibrillator surgeons implant into patients used to treat arrhythmia, or irregular heartbeat. Cardio resynchronization therapy defibrillators, or CRT-Ds, are about the same size and perform roughly the same function. St. Jude Medical, a Minnesota-based company that specializes in cardiovascular medical devices, sells several models of both types of these devices.
Both types of implantable defibrillators can fit in the palm of a person’s hand and are implanted in the upper chest near the heart. Small wires called leads connect the device to the patient’s heart and read their heartbeat. If the heart ever experiences arrhythmia, the defibrillator delivers a small pulse via the leads to shock the heart back into correct rhythm.
The St. Jude Medical defibrillators are designed to treat:
- Arrhythmia, or irregular heartbeat
- Bradycardia, or slow heartbeat
- Tachycardia, or fast heartbeat
- Premature ventricular contractions, or extra heartbeats
People who suffer from these conditions and therefore require these implantable defibrillators have often experienced:
- Heart attack
- Previous heart surgery
- Congenital heart disease
- Heart failure
- Long QT Syndrome
Although ICDs and CRT-Ds are battery operated and designed to last for five to 10 years, St. Jude Medical recalled several of these devices in 2015 and 2016 for premature battery failure. These defective defibrillators can be deadly. Without battery power, the implantable defibrillators will not be able to monitor a patient’s heart and deliver life-saving electric shocks.
St. Jude Medical and FDA Defibrillator Recalls
On Oct. 10, 2016, St. Jude Medical released a recall of several models of its ICDs and CRT-Ds due to reports of premature battery failure. The next day, the FDA distributed a safety communication alerting the public of this potential problem.
According to the FDA report, 349,852 St. Jude Medical defibrillators were implanted worldwide as of Oct. 11, 2016. Of the 398,740 that had been sold up until that time, 841 were returned to St. Jude Medical for rapid-battery depletion.
St. Jude Medical ICDs and CRT-Ds are powered by lithium batteries. When functioning properly, the batteries last between five and 10 years. Patients who receive these implants are advised of a small vibration the device may make, called an elective replacement indicator alert. When a patient notices an ERI, they are encouraged to get the battery replaced within three months.
In accounts of premature battery depletions, however, some patients’ ICDs failed within 24 hours of the ERI alert. Inspections have shown lithium clusters cause this problem. A lithium cluster, or deposit, sometimes occurs in lithium-based batteries, causing abnormal electrical connections that lead to battery failure.
At the time of the FDA communication, rapid battery depletion had caused two patient deaths, 10 cases of patient fainting and 37 cases of patient dizziness ‑ all directly related to the device’s inability to distribute defibrillator shocks. Both the FDA communication and the St. Jude Medical recall asked patients, patient caregivers and loved ones to report to their doctor or hospital immediately if they were implanted with an affected defibrillator and experienced an ERI alert.
St. Jude Medical knew about the problem as early as 2014, according to one news report, after an independent study conducted by Duke University Medical Center researchers noticed lithium cluster formation occurring at a 0.6 percent rate. The St. Jude Medical board of advisors recommended the company collect more data before issuing a warning advisory.
Nearly one year earlier, on Nov. 3, 2015, St. Jude Medical and the FDA also issued a recall on certain models of its Optisure Dual Coil Defibrillation Leads. It was found a manufacturing error damaged the insulation layer on the shock coils, causing the devices to malfunction and fail to distribute electrical therapy to the patient.
St. Jude Medical recalled several different medical defibrillator products, and in most cases, several different model numbers per product. In November 2015, St. Jude Medical recalled the Optisure Dual Coil Defibrillation Leads. Specifically, four different model numbers manufactured between March 12, 2014 and March 22, 2015 were recalled.
In October 2016, St. Jude Medical recalled 13 different implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator products. The recall included 39 different model numbers manufactured before May 2015.
These recalled St. Jude Medical ICDs and CRT-Ds are:
- Fortify VR, models CD1231-40, CD1231-40Q
- Fortify ST VR, models CD1241-40, CD1241-40Q
- Fortify Assura VR, models CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
- Fortify Assura ST VR, models CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
- Fortify DR, models CD2231-40, CD2231-40Q.
- Fortify ST DR, models CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
- Fortify Assura DR, models CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
- Fortify Assura ST DR, models CD2363-40C, CD2363-40Q
- Unify, models CD3231-40, CD3231-40Q
- Unify Quadra, models CD3249-40, CD3249-40Q
- Unify Assura, models CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
- Quadra Assura, models CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
- Quadra Assura MP, models CD3269-40, CD3269-40Q, CD3369-40C
The recalled St. Jude Medical Optisure Dual Coil Defibrillation Leads model numbers are:
St. Jude Medical Defibrillator Treatment Options
Both the St. Jude Medical recall notices and FDA advisories outline recommended courses of action for patients affected by the device advisory. Similar instructions were also detailed for healthcare providers.
According to the St. Jude Medical advisory, patients with possibly affected devices are advised to pay attention to their device for the ERI alert. All patients who experience this alert are urged to visit their doctor promptly. Their physician may have also received the same alert and could possibly contact the patient to request an examination.
This is possible through the [email protected] program, a remote monitoring program some St. Jude Medical devices can participate in. If a patient’s device is capable of remote monitoring, is affected by the advisory and isn’t already set up, the person’s physician may contact them about enrolling in the program. This will allow their doctor to monitor the device in case of any ERIs without requiring the patient to come in for regular office visits.
In addition, the advisory notes that removing the St. Jude Medical defibrillator is not a recommended course of treatment unless the patient has experienced an ERI or their doctor has determined it as the best course of action. If removal is determined to be the best course of treatment, the patient must participate in a minimally invasive surgery to remove the defibrillator.
The FDA also recommends patients or physicians contact the agency if they experience rapid battery depletion. Making a voluntary report to MedWatch, the FDA Safety Information and Adverse Event Reporting system, helps the FDA monitor the problem with St. Jude Medical defibrillators and possibly issue future warnings to other users.