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(May 2007) Boston Scientific/Guidant recalls 73,000 implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) in April 2007.
As of March 30, 2007, Boston Scientific, as reported by the FDA. A capacitor in the affected devices could malfunction, leading to premature battery depletion. By the end of March, Boston Scientific had confirmed 19 field events with Guidant’s devices, mostly related to battery depletion. There were no injuries or deaths reported. Patients who have a device affected by the recall should consult with their physicians on the next steps to take.
Designed for portable, battery-powered medical applications, TLM-1550H features 2 Watt hours of energy at 4.0 Volts. The product has open circuit voltage of 4.1 Volts and can handle pulses up to 15 Amps, with 5 Amps continuous load. The battery offers up to 20 years of storage life and is suitable for medical devices such as automatic external defibrillators, CPT resuscitation equipment and surgical power tools.
(July 2006) Boston Scientific recalls some pacemakers and implantable cardioverter defibrillators (ICDs) in late June 2006.
The products were manufactured by the company’s recently acquired cardiac rhythm management business - Guidant. Pacemakers recalled include Insignia and Nexus pacemakers, as well as the Contak Renewal TR/TR2 cardiac resynchronization pacemaker. ICD recalls include the Ventak, Prizm2, Vitality and Vitality 2.
As of the date of the announcement, 27,000 already implanted devices could potentially have a problem . The recall is a result of a a capacitor (built by an outside supplier) which can cause a malfunction in the devices, including premature battery depletion.
To date five patients have had problems although there have no deaths. It is recommended by Boston Scientific that patients having these implantable devices see their physicians at the earliest opportunity.
(April 2006) Guidant issues warning on low battery Voltage in some of its implantable defibrillators.
On March 13, 2006, the company noted that it had received 39 reports stating the devices had exhibited lower than expected battery Voltage prior to implant. The company says the “unexpected” sustained, low-level current can only occur during the storage or shipment of the device prior to implant. This warning by the company is voluntary and at the date of this writing (3/15/05) , the FDA had not classified this communication as a recall.
(March 2006) National Center for Design of Biometric Nanoconductors is to be established at the University of Illinois at Urbana-Champaign.
The National Eye Institute of the US National Institutes of Health has offered a $6.5 million grant to develop nanotech batteries which can be implanted in artificial organs. The first batteries would be utilized by the Doheny Eye Institute at the University of California for powering an artificial retina. Sandia National Laboratories, a grant recipient, will use multi-scale modeling to understand and predict how transporter structure leads to function, with an initial focus on specialized tranporters found in the electric eel. Susan Rempe, a principal investigator at Sandia, said, “This information will give us a better understanding of how power is naturally created in biological organisms in order to design and build the nanobattery.” The ultimate goal is to use silica technology for development of the battery which is to be implanted in the cranium to provide long-term power for an artificial eye.
On September 16, 2005, the U. S. Food & Drug Administration approved the first portable defibrillator which can be purchased without a doctor’s prescription. With combined simplicity and ease of use, unskilled people can operate the defibrillator. It has an affordable price which has already seen a drop from $1300 to under $1000.
The need for a simple, affordable automated external defibrillator (AED) stems from experiential data which shows that 70% of all cardiac arrests occur in the home. Calling Emergency Services or looking for an available AED drops survival to 7-10%. With universal availability and immediate applicability, the survivability rate should increase.
Highlighted were the considerations of the battery, evidently using Lithium-ion chemistry because of the mention of such things as power management, safety, standby and pulsed operations. (Ed. Note: As the installed defibrillators age, the quality of the power management design, will be revealed if users are properly informed of impending battery problems relating to state of charge, cycle life and calendar life.)
Electronic Design, December 15, 2005