St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
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. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices. The devices addressed in this communication are the following St. Jude Medical ICD and CRT-D models manufactured before May 2015:
FDA is providing information and a recommendation regarding St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected. FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. At this time, the FDA recommends that patients, patient caregivers, and health care providers enroll in and utilize the St. Jude Medical Merlin@Home monitoring system to help detect battery depletion. The FDA is investigating cybersecurity concerns associated with these devices, including the Merlin@Home. The ICD and CRT-D devices identified in this safety communication provide life-saving therapy, and the FDA believes that the benefits of monitoring outweigh any potential cybersecurity vulnerabilities.
FDA is encouraging people to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
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Photo: St. Jude Medical Ellipse(TM) ICD (Photo: St. Jude Medical)