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 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 <ABT.N>.
The letter said problems with the lithium batteries were rare and
could be identified by patients using tools for monitoring battery
levels at home.
Patients should seek immediate medical attention as soon as they get
a low-battery alert from the monitoring devices, the U.S. 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.
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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.
Battery-depletion recalls or advisories have been issued in the past
two years by Boston Scientific Corp and Medtronic Plc, with no
visible impact on company businesses, according to Barclays analyst
Matt Taylor.
Medtronic in November recalled three models of its InSync III
pacemakers due to battery problems, but overall company pacer sales
continued to grow sharply thanks to newer products, Taylor said.
Boston Scientific in September 2014 alerted doctors of potential
battery-life problems with two ICDs, and recommended that patients
upgrade their software.
St. Jude advised patients to check its website for details on which
devices were affected by the battery issue. (http://www.sjm.com/batteryadvisory).
(Reporting by Jim Finkle in Boston, Ransdell Pierson in New York and
Ankur Banerjee and Natalie Grover in Bengaluru; Editing by Nick
Zieminski and Lisa Shumaker)
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