St Jude warns of battery defect in some heart devices
Two deaths spark recall of device
WASHINGTON, Oct 12, (Agencies): 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.
The company said Tuesday that two deaths have been linked to the problem and 10 more patients fainted because the devices stopped working.
St Jude said the batteries should be replaced immediately after patients receive an electronic, vibrating alert from the device. Normally patients have up to three months to have batteries replaced. But the company said a small subset of its heart-shocking defibrillators can fail within 24 hours of the alert. The problem affects a subset of its Fortify, Quadra and Unify devices. Specific model and serial numbers are available on St Jude’s website.
The metallic implants are used to treat dangerous heart rhythms that can lead to cardiac arrest, heart failure and death.
Buildup
The design flaw is caused by buildup of deposits around lithium batteries that power the devices. St Jude said it fixed the issue in May 2015 and removed all affected devices from distribution and hospital inventories.
Nearly 350,000 patients worldwide could have devices affected by the issue, according to a separate statement from the Food and Drug Administration. As in similar cases, regulators are not recommending that patients with the devices have them preemptively removed. That’s because the risks of the surgical procedure are generally much higher than the potential harms of the defect itself.
St Jude noted the actually prevalence of the issue is very rare: “the vast majority of devices sold worldwide have not experienced premature battery depletion.”
All major manufacturers of implantable heart defibrillators have reported malfunctions and
recalls, including competitors Medtronic Inc., Boston Scientific and St Jude itself. In 2010, the St Paul, Minnesota-based company stopped selling defibrillators with certain wires because they could prematurely crack and fail. Last year the company paid $14.5 million to settle hundreds of lawsuits filed by customers who received devices with the wires.
The devices 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.
“There have been two deaths that have been associated with the loss of defibrillation therapy
as a result of premature battery depletion,” St Jude’s vice president of quality control, Jeff Fecho, said in an advisory to physicians on Tuesday.
The devices were introduced in 2010 and are meant to last for seven years or longer, until their batteries are depleted, the company said. 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.
The company said the recall is not expected
to have a material financial impact on the company, although many patients are expected 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.”
News of the issue surfaced late on Monday when short-selling firm Muddy Waters tweeted a copy of a physician advisory from St Jude, which agreed in April to sell itself for $25 billion to Abbott Laboratories. The letter said problems with the lithium batteries were rare and could be identified by patients using tools for monitoring battery levels at home.
Alert
Patients should seek immediate medical attention as soon as they get a low-battery alert from the monitoring devices, the US Food and Drug Administration said, in announcing the recall.
“Hospitals should immediately remove any unused devices affected by this recall, and contact the manufacturer to receive corrected devices,” the FDA said.
Wedbush Securities analyst Tao Levy said the recall would likely cost St Jude no more than “a few million dollars” because relatively few patients will need early replacements and devices now being sold have improved and reliable batteries.
St Jude’s shares fell 3.5 percent, while Abbott’s declined 5.4 percent. Abbott said it still expects to close the St Jude deal this year.
The recall comes 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 on Tuesday its investigation into the cyber security vulnerabilities of the devices, including the Merlin@Home monitoring system, was continuing.
“Despite the allegations, at this time, the FDA 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,” the FDA said in a statement.