Boston Scientific issues safety alert for Guidant pacemakers and
defibrillators
27 June 2006 Natick, Mass., USA. Boston Scientific Corporation (NYSE:
BSX) announced that it is providing safety information and retrieving a
specific subset of pacemakers, cardiac resynchronization pacemakers and
implantable cardioverter defibrillators from its sales force and hospital
inventories. These products are manufactured by the Company's Cardiac
Rhythm Management (CRM) Group, formerly Guidant's CRM business. Boston
Scientific acquired Guidant on April 21. It follows a series of safety
alerts, recalls, investigations and lawsuits involving Guidant in 2005, when
about 109,000 defibrillators were recalled.
Boston Scientific shares have suffered a sharp decline in June and are
now the lowest since late 2002. Shares dropped to a low of 16.47 on 27 June,
compared to a 52-week high of 29.35 and a peak of nearly 45 in May 2004.
The specific subset of devices includes INSIGNIA and NEXUS pacemakers,
CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM
2, VITALITY, and VITALITY 2 implantable cardioverter defibrillators.
Boston Scientific CRM has recently identified a supplier's low-voltage
capacitor that is not performing to the company's expectations. A capacitor
is an electrical charge storage component. Some capacitors from specific
lots may perform in a manner that leads to device malfunction, including
intermittent or permanent loss of therapy or premature battery depletion. To
date, a total of five confirmed events have been reported out of
approximately 27,200 implanted devices from this subset. One event involved
a device malfunction discovered at the time of implant. The other four
events involved devices that were implanted and subsequently required
replacement. Boston Scientific says that patients with affected pacemakers
may experience intermittent or permanent loss of output or telemetry, or
premature battery depletion. Patients with affected defibrillators may
experience inappropriate sensing or premature battery depletion. There have
been no reported patient deaths associated with this issue. There have been
two reports of pacemaker patients experiencing syncope associated with loss
of pacing output. Engineering analysis is ongoing and the company will
further communicate on this issue when it has additional information.
Implanting and following physicians are being asked to schedule an in-clinic
follow-up visit as soon as possible for all patients with implanted devices
from this subset to assess device function. At this follow-up visit,
physicians should look for behaviours that may be indicative of capacitor
malfunction such as premature battery depletion, intermittent or permanent
loss of therapy or telemetry, fault codes, pacing or sensing abnormalities,
or loss of daily measurements. "Boston Scientific believes in notifying
physicians in a timely, transparent and responsible manner," said Jim Tobin,
Boston Scientific President and Chief Executive Officer. "This action
reflects Boston Scientific's industry-leading commitment to implementing
recommendations made by both the Heart Rhythm Society and the Independent
Panel Commission chaired by Dr Robert Myerberg. Boston Scientific is the
only CRM company that has committed to implementing these recommendations,
which it believes are in the best interest of patients and physicians."
Physician communications can be viewed in their entirety at
http://www.guidant.com/physician_communications/
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