|
St. Jude warns of
heart-device battery issue linked to two deaths
Send a link to a friend
[October 11, 2016]
By Jim Finkle
(Reuters) - St. Jude Medical Inc warned on
Tuesday that some of its implanted heart devices are at risk of
premature battery depletion, a condition it said has been linked to two
patient deaths and could require the replacement of some devices.
|
|
 News of the issue surfaced on Monday evening when short-selling firm
Muddy Waters tweeted a copy of a physician advisory on the matter
from St. Jude, which agreed in April to sell itself for $25 billion
to Abbott Laboratories.
That letter said such problems with the lithium batteries that power
the devices were rare and could be identified by patients using
tools for monitoring battery levels from their homes.
Out of nearly 400,000 devices manufactured through May of last year,
the company has identified 841 failed implanted cardioverter
defibrillators with lithium clusters, which can form after a device
delivers electricity to the heart, according to St. Jude.
Lithium clusters sometimes cause battery power to deplete quickly,
making devices unable to deliver doses of electricity when needed,
St. Jude Vice President of Quality Control Jeff Fecho said in the
letter to physicians.
"There have been two deaths that have been associated with the loss
of defibrillation therapy as a result of premature battery
depletion," Fecho said.
The company advised physicians to replace devices with damaged
batteries immediately, but cautioned against swapping out devices
that were operating normally because of the potential for
complications from such procedures.
“We encourage any patient with questions about their medical device
to contact their doctor," St. Jude Chief Medical Officer Mark
Carlson said in a statement.
"While this risk is very small, we have provided doctors with
information so that they can discuss the most appropriate course of
action for each individual patient,” Carlson said.
[to top of second column] |
St. Jude said it planned to launch a webpage on Tuesday where
patients could see which devices were affected: (http://www.sjm.com/batteryadvisory).
The site tells patients how they can monitor battery activity, look
for vibrating alerts when batteries are low and connect to the
Merlin.net remote monitoring service.
The alert comes as St. Jude defends itself against unrelated
allegations that its heart devices are riddled with bugs that make
them vulnerable to fatal cyber hacks.
The Food and Drug Administration is investigating the claims by
Muddy Waters and research firm MedSec Holdings Inc.
St. Jude has denied the allegations and sued both firms, saying they
disseminated false information to manipulate its stock price.
(Reporting by Jim Finkle in BOSTON; Editing by Paul Tait)
[© 2016 Thomson Reuters. All rights
reserved.] Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
