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Medical device maker St. Jude Medical is warning doctors and patients about a rare battery defect in some of its implantable heart devices that can cause them to fail much earlier than expected. Almost 350,000 people around the world have defibrillators affected by the issue.
St. Jude’s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) provide electric shocks to help regulate a patient’s heartbeat. The devices are implanted under the skin with wires connecting to the patient’s heart. Patients are outfitted with the devices if they suffer from an unusually slow heartbeat, called bradycardia, or an unusually fast heartbeat, called tachycardia.
The effected devices are:
- Fortify Assura DR
- Fortify Assura VR
- Fortify DR
- Fortify ST DR
- Fortify ST VR
- Fortify VR
- Quadra Assura
- Quadra Assura MP
- Unify Assura
- Unify Quadra CRT-D
The devices are battery powered, and patients receive a new battery every three months. However, the batteries are lithium-based, and this can cause complications when deposits of lithium build up within the battery. The buildup of lithium deposits – called lithium clusters – creates an abnormal electrical connection that can cause rapid battery failure.
St. Jude said that two deaths have been linked to the problem with 10 more patients losing consciousness after the devices stopped working. The company did say, however, that the issue is rare: “The vast majority of devices sold worldwide have not experienced premature battery depletion.”
For Further Information
More on the markets for cardiac rhythm management devices can be found in our upcoming report published by iData entitled US Markets for Cardiac Rhythm Management, which covers the U.S. as a whole, as well as market segments for pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, cardiac lead, external defibrillators, cardiac ablation, diagnostic electrophysiology devices, and electro-cardiograph and cardiac monitoring devices.
The iData series on the market for cardiac rhythm devices also covers the U.S., and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. Register online or email us at [email protected] for an US Markets for Cardiac Rhythm Management Devices report brochure and synopsis.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
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iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.
About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics, Dental Operatory Equipment and more.
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