Cochlear Nucleus CI512 Recall
Shoop | A Professional Law Corporation is now handling multiple cases involving
the Cochlear Ltd., CI512 Implant.
Cochlear Ltd., the device manufacturer, has issued this product recall
for the Nucleus CI500 range, of which there are approximately 28,000 users.
Cochlear Ltd. had this device on the market as early as 2009, and the device
is now experiencing multiple, post-implant failures. The company maintains
that it is still "investigating the cause of these failures."
The Nucleus CI 500 line accounted for approximately 70% of Cochlear sales in 2011.
Cochlear will of course be required to run clinical tests and win regulatory
approval from the U.S. Food and Drug Administration to return these devices
to market. FDA can take up to 180 days to review data.
Cochlear Ltd., Chief Executive, Chris Roberts, advised that the company
was in no rush to conclude an investigation into the cause of these multiple,
device failures, which relates to moisture in the devices that can cause
a malfunction in one or more diodes. "Advice to clinics suggests
that analysis of the moisture indicates that it is not related to body
fluid," UBS analyst Andrew Goodall said. If this is indeed the cause,
this would implicate an obvious flaw in the manufacturing process for
which Cochlear Ltd. is strictly liable in tort.
In July of 2011, just two (2) months before Cochlear, Ltd., issued a voluntary
recall for the Nucleus CI500 range of cochlear implants, Cochlear Ltd.,
notified physicians in a Clinical Product Update that the ground electrodes
in some Nucleus CI512 implants (claimed to be less than 0.3%) had open circuits.
This product defect means that while the Nucleus has two electrodes, one
of the electrodes was failing. Cochlear assured physicians that the primary
purpose of having two electrodes was for redundancy, and that if the Monopolar
2 (MP2) ground electrode failed, that the default mode of stimulation
for mapping would become Monopolar 1(MP1).
Cochlear also acknowledged that the intended stimulation mode for mapping
was a combination of both electrodes MP1+MP2. Cochlear Ltd. indicated
that a patient's hearing performance would not be affected if the
MP2 ground electrode failed because of an open circuit. Cochlear Ltd.,
also stated that if a surgeon implanting the device identified through
impedance testing that the MP2 electrode was open, that the surgeon should
decide whether to use a different device.
However, Cochlear Ltd. did not state that the Nucleus CI512 was defective
in manufacture or design. Instead, Cochlear Ltd. represented that it had
identified the mechanism causing the open circuit in the MP2 ground electrode,
and that it was putting in place processes to correct the defect. With
regard to the use of the Nucleus CI500 Range, Cochlear stated that it
would always support the surgeon's decision on whether to use the
device. Moreover, Cochlear Ltd., Chief Executive, Chris Roberts, advised
that the company was in no rush to conclude an investigation into the
cause of these multiple, device failures, which reportedly relates to
moisture in the devices that can cause a malfunction in one or more diodes.
"Advice to clinics suggests that analysis of the moisture indicates
that it is not related to body fluid," UBS analyst Andrew Goodall
said. If this is indeed the cause, this would implicate an obvious flaw
in the manufacturing process for which Cochlear Ltd. is strictly liable in tort.
The global financial services firm, UBS, are predicting that the failure
rate for the Nucleus CI512 is approaching 6%.
Please see our previous blog entry, here:
Cochlear Americas is sending letters to users of the device and the parents
of minors who have a Nucleus CI512 that has failed, offering to work with
the patient's insurance company to replace what would appear to be
defective in both design and manufacture. Shoop | A Professional Law Corporation
recommends that patients and parents of minors not release any of their
rights to recovery for injuries sustained and financial losses, without
first consulting an attorney who has substantial experience in the investigation
of defective products, and litigating cases involving defective medical
devices. If you or a family member has suffered a failure of the Cochlear
Ltd., CI500 series implant,
contact Shoop | A Professional Law Corporation today to speak with an experienced
Los Angeles product liability attorney, toll free, at