resize_shutterstock_576434On October 11, 2016, FDA MedWatch published a notice applicable to patients, caregivers, risk managers and cardiologists regarding St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out of necessary power within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices. See the table below for a list of St. Jude Medical ICDs and CRT-Ds FDA of affected devices.

St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

St. Jude Medical has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.
Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known. At this time, 349,852 affected devices remain actively implanted worldwide.

The FDA will continue to monitor affected St. Jude Medical ICD and CRT-D devices for any adverse events related to premature battery depletion or cybersecurity vulnerabilities, and the agency will keep the public informed as new information becomes available.

The FDA has published a Safety Communication for a complete listing of recommendations for healthcare providers and patients. Healthcare professionals recommendations are listed below:

Do not implant unused affected devices. Premature battery depletion due to lithium clusters has only been observed in devices manufactured prior to May 2015. At this time, there is no information indicating that this issue affects devices manufactured after this date.
Communicate with all patients who have an affected device that their device has a battery that may run out earlier than expected. Consider giving patients the Dear Patient letter provided by St. Jude Medical.
Continue to conduct follow-up on patients with affected devices using in-office visits in addition to remote monitoring once they have been notified of the battery issue. Increased in-office surveillance is not necessary for patients who are also followed with remote monitoring.
Immediately replace the device at the time of an ERI alert. Currently, there is not a factor, method, or test to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once ERI appears.
Pacemaker-dependent patients with a device that has reached ERI should be treated as a medical emergency.
Health care providers should consider whether elective device replacement is warranted for their pacemaker dependent patients. Ultimately, health care providers should individualize the care of their patients based on the patients’ medical history, comorbidities and condition.
Most patients will not require prophylactic device replacements prior to ERI as the rate of complications following replacement surgery are higher than those associated with premature battery depletion. However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.
Enroll patients in Merlin@Home, St. Jude Medical’s home monitoring system for these devices, especially those who have difficulty recognizing their device’s ERI alerts. For patients already enrolled in Merlin@Home, explain the importance of ongoing home monitoring. Utilize the “Direct Alerts” feature to provide you with an alert notification when a patient’s device has reached ERI. Please see additional information about the Merlin@Home Monitoring System below. If a home monitor is ordered for a patient with an affected device, St. Jude Medical will cover the cost of the home monitor.
Ensure that the ERI battery alert is ON for all patients. Review the most recent “Programmed Parameters” printout.

TABLE OF AFFECTED DEVICES: The devices addressed in this communication are the following St. Jude Medical ICD and CRT-D models manufactured before May 2015. Patients can learn if their device is included in the advisory by visiting a dedicated webpage: www.sjm.com/batteryadvisory . Patients are encouraged to immediately contact their health care provider if they have any questions regarding their implantable device.

MANUFACTURER MODEL AFFECTED
St. Jude Medical Fortify VR
St. Jude Medical Fortify ST VR
St. Jude Medical Fortify Assura VR
St. Jude Medical Fortify Assura ST VR
St. Jude Medical Fortify DR
St. Jude Medical Fortify ST DR
St. Jude Medical Fortify Assura DR
St. Jude Medical Fortify Assura ST DR
St. Jude Medical Unify
St. Jude Medical Unify Quadra
St. Jude Medical Unify Assura
St. Jude Medical Quadra Assura
St. Jude Medical Quadra Assura MP

 

Links/References:

  1. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm524706.htm
  2. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm524666.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
  3. http://media.sjm.com/newsroom/news-releases/news-releases-details/2016/St-Jude-Medical—Important-Medical-Device-Advisory/default.aspx