Boston Scientific has
recently provided physicians with important product advisory information
regarding the COGNIS® and TELIGEN® families of implantable defibrillators. Most
defibrillators are implanted just under the skin in the upper chest area. Less
commonly, a doctor may choose to implant a device deeper, under the chest
muscles. Boston Scientific has learned that some devices implanted under
the chest muscles may be subject to mechanical stresses from rigorous body
motion. These stresses have the potential to weaken the bond between the device
casing and the lead connector, or header, portion of the device, and could
impact the ability to deliver appropriate therapy.
They have received two (2)
reports worldwide of implants located under the chest muscles with weakened
header bonds. The patients implanted with these devices received
inappropriate shocks and required early device replacement. It is important to
note that only COGNIS/TELIGEN devices that have been implanted below the chest
muscles are affected by this advisory. We estimate that this implant
orientation is used in only about 5% of implants worldwide. Devices implanted
under the skin are not affected by this advisory.
They have communicated this
information to physicians and the FDA is aware of this issue.
Here’s what patients can
do:
Check your ID card to determine whether you have a
COGNIS or TELIGEN device. If you don’t, this advisory does not apply.
Talk to your doctor to determine whether your device is
implanted between the chest muscle and the skin, or under the chest
muscle. If it is implanted between the chest muscle and skin, this
advisory does not apply.
Be sure and keep your regular device follow-up
appointments.
Contact your device doctor or clinic if you receive a
shock.
Information on this
advisory is publicly available on their website, www.bostonscientific.com under the Product Performance
Resource Center
link. This information includes patient and physician letters and a device
lookup tool.
If you have more questions,
contact the Boston Scientific Patient Services team by calling 1.866.484.3268
and pressing “2” when prompted.
