St. Jude Medical Implantable Cardioverter Defibrillators Subject of Recall Following Deaths. Jude Medical Inc. recently announced a recall of about 40 implanted heart devices over risks of premature battery depletion. The defect has been associated with two deaths. The U.S. Food and Drug Administration (FDA) has deemed the recall a Class I, which is the agency’s most serious type of recall and indicates that use of these devices may lead to serious injuries or death.
St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are medical devices that provide pacing for bradycardia (slow heart rhythms), provide electrical shock to stop tachycardia (dangerously fast heart rhythms), or provide coordination when needed to treat heart failure. Both ICD and CRT-D devices are implanted under the skin in the upper chest area and are connected with leads (insulated wires) that are placed within the heart.
St. Jude Medical has recalled specific models of the Fortify, Unify, and Assura ICDs and CRT-Ds over reports of rapid battery failure resulting from deposits of lithium, or “lithium clusters,” which form within the battery and create abnormal electrical connections leading to a short circuit. Should the battery run out unexpectedly before the patient is aware of the rapid battery drain, the ICD or CRT-D will not be able to deliver life-saving pacing or shocks, which may lead to patient death.
The FDA and St. Jude Medical are advising patients, patient caregivers, and physicians to immediately respond to the Elective Replacement Indicator (ERI) alert. Because of the issues associated with St. Jude ICDs or CRT-Ds batteries, patients do not receive the normal three-month lead-time typical for device replacement. In fact, some batteries have depleted within 24 hours of the patient receiving an ERI alert. In addition to the recall, St. Jude Medical has also initiated correction of affected devices.
Parker Waichman LLP is a national law firm with decades of experience representing individuals injured by defected medical devices. The firm continues to offer free legal consultations to individuals with questions about filing a defective medical device injury lawsuit.
The recalled Fortify, Unify, and Assura ICDs and CRT-Ds contain “Manufacturing Dates” from January 2010 to May 2015, and “Distribution Dates” from February 2010 to October 2016. A total of 251,346 devices were recalled in the United States of the 398,740 affected devices that were sold worldwide. A total of 841 devices were returned for analysis over premature battery depletion. The full list of recalled devices with model numbers follows:
- Fortify VR: Model No(s). CD1231-40, CD1231-40Q
- Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
- Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
- Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
- Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
- Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
- Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
- Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
- Unify: Model No(s). CD3231-40, CD3231-40Q
- Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
- Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
- Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
- Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C
Federal regulators indicate that patients implanted with a St. Jude Medical ICD or CRT-D device, their caregivers, and their health care providers should be made aware of the recall and advised that, on October 10, 2016, St. Jude Medical sent notification letters to customers and health care providers to advise them of the potential of premature battery depletion in the affected ICD and CRT-D devices. Also, on October 11, 2016, the FDA issued a safety communication concerning the recall and provided recommendations for health care providers, patients, and caregivers.
Patients at most risk are those individuals with an increased likelihood of needing life-saving shocks and those individuals who are pacemaker dependent.
To date, two deaths-one that occurred in the United States-have been tied to the impacted devices that were unable to provide necessary shock therapy over premature battery depletion. Ten other patients-nine in the U.S.-reported fainting from devices that were unable to provide necessary pacing therapy when the battery depleted prematurely. Another 37 patients-30 in the U.S.-reported dizziness over devices that were unable to provide necessary pacing therapy due to premature battery depletion. Because battery depletion is not always reported to St. Jude, the actual number of devices impacted with premature battery depletion over lithium cluster issues remains unknown.
The St. Jude devices may be programmed to deliver a vibratory patient alert should the battery has reach ERI. The device maker’s home monitoring system may also be used to monitor battery status and does provide health care provider notifications. These may be helpful options for some patients given the risk of surgical procedure complications; however, because battery depletion may occur quickly after an ERI and some patients may not detect the device alert, these options may not be sufficient for all patients, especially patients dependent on their device for pacing and who are diagnosed with an untolerated or absent intrinsic heart rate. Health care providers should consider if elective device replacement is appropriate for their pacemaker-dependent patients.
The agency advises, in part, that physicians are also advised against implanting an unused affected St. Jude ICD or CRT-D device. Premature battery depletion involved with lithium clusters has been observed in those devices made before May 2015. Physicians should also advise their patients implanted with these devices about the likelihood of the battery running out prior to expected and consider providing patients with the letter written by St. Jude medical. Also, follow-up on patients implanted with these devices with office visits and remote monitoring; replace the device upon ERI alert. Pacemaker-dependent patients implanted with a device that reached ERI are to be treated as a medical emergency and consider if elective device replacement is called for pacemaker-dependent patients. Also, ensure the ERI battery alert is “ON” for all patients.