St. Jude Medical Inc. is recalling some of its 400,000 implanted heart devices due to risk of premature battery depletion, a condition linked to two deaths in Europe. The devices are used to shock dangerously racing heartbeats back to their normal rhythm or to treat heart failure. All the devices, called ICDs and CRT-Ds, contain batteries that were manufactured before May 23, 2015, when the company added insulation to reduce the chance of an electrical short circuit. St. Jude’s vice president of quality control, Jeff Fecho, said in an advisory to physicians on Oct. 9: “There have been two deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion.”
The devices were introduced in 2010 and are meant to last for seven years or longer, until their batteries are depleted, according to the company. They are designed to vibrate at regular intervals once power is diminished, a signal to patients that they should visit their doctors for replacements within 90 days. In addition, a home monitoring unit wirelessly reads the battery level and other information and routinely sends details to doctors.
The company said one of the patients died after his vibration signal indicated low power, but a few days before his planned replacement. Many patients are expected by the company to visit their doctors and some could request early replacements.
St. Jude said 841 devices had been returned to the company for analysis due to premature battery depletion, traced to a build-up of lithium clusters in the batteries. Mark Carlson, medical officer of St. Jude, said in an interview the company’s advisory board of physicians has strongly recommended that most patients not seek prophylactic replacements “because the risk associated with replacing the devices outweighs the low risk of a patient problem occurring.”
The U.S. Food and Drug Administration (FDA) said that patients should seek immediate medical attention as soon as they get a low-battery alert from the monitoring devices. In announcing the recall, the FDA said: “Hospitals should immediately remove any unused devices affected by this recall, and contact the manufacturer to receive corrected devices.”
This recall came as St. Jude is defending itself against unrelated allegations that its heart devices are riddled with defects that make them vulnerable to cyber hacks. Those claims were made by Muddy Waters and research firm MedSec Holdings. St. Jude has denied the allegations and sued both firms. The FDA said last month its investigation into the cyber security vulnerabilities of the devices, including the Merlin@Home monitoring system, is continuing.
Despite the allegations, at this time, the FDA says it strongly recommends that the Merlin@Home device be used to monitor the battery for these affected devices “because the benefits of continued patient monitoring and the life-saving therapy these devices provide greatly outweighs any potential cybersecurity vulnerabilities.”
It appears that relatively few patients will need early replacements and that devices now being sold have improved and reliable batteries. St. Jude advised patients to check its website for details on which devices were affected by the battery issue. (www.sjm.com/batteryadvisory).
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