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Q: Medical Device Malfuncioning ( Answered,   1 Comment )
Subject: Medical Device Malfuncioning
Category: Health > Medicine
Asked by: ballay-ga
List Price: $50.00
Posted: 11 May 2004 15:58 PDT
Expires: 10 Jun 2004 15:58 PDT
Question ID: 344867
What information exists on cochlear implants manufactured by Advanced
Bionics Corporation involving FDA applications, rejections,
investigations, warnings & approvals,  violations of the Safe Medical
Devices Act (U.S. federal) and, in particular, of the devise known as
Clarion II implant.  Have there been any successful lawsuits involving
malfunctioning cochlear implants of Advanced Bionics Corporation?  (
$50.00 )

Request for Question Clarification by pafalafa-ga on 11 May 2004 17:02 PDT
Hmmm...where to begin?

FDA has issued a warning on cochlear implants risks for implants from
Advanced Bionics and from another company as well.  The warning has to
do with increased risks from meningitis.

There are over 1,000 adverse events reports (malfunctions, problems,
complaints, etc) in FDA databases pertaining to Advanced Bionics.

I've no doubt there are lawsuits, though I haven't looked yet. 
However, the history of the cochlear implants is perhaps too recent
for the lawsuits to have reached conclusion, making it hard to provide
information, and harder still to say whether any of them have been
"successful" or not.

If you would like, I can provide an answer to your question that:

--provide links to the FDA complaints database, so you can see any (or
all!) of the incidents pertaining to Advanced Bionics.

--provide links to FDA documents and/or news articles about the FDA
warning on cochlear implants.

--search for information on any pending lawsuits and provide brief
summary information on legal activities (if any) that I uncover.

Let me know if you would like me to post this information as an answer
to your question.

If not, please let us know what additional information you would like
to have to make for a satisfactory answer.



Clarification of Question by ballay-ga on 12 May 2004 06:35 PDT
The issues you list are fine.  The cochlear implant malfunctioned and
had to be replaced.  It did not involve meningitis or any type of
infection.  If more info is needed please contact me.  thanks
Subject: Re: Medical Device Malfuncioning
Answered By: pafalafa-ga on 12 May 2004 08:32 PDT
Hello again, ballay-ga.  Thanks for clarifying your situation...that
was a big help with my research.

I've reported my findings below, and also provided you links where you
can find additional information.

I hope this will provide you all the details you need about the Clarion implants.  

Before rating this answer, though, please let me know if there's
anything here that is not clear, or if you need additional
information.  Just post a Request for Clarification, and I'll be happy
to assist you further.

All the best,




The FDA approves and regulates medical devices such as cochlear
implants, and also maintains extensive records about any problems or
complaints associated with the devices.

The major database containing reports of problems with medical devices
is known as MAUDE --
Manufacturer and User Facility Device Experience Database.   You can
access MAUDE directly at:

This is the advanced search function, which allows a good deal of
selectivity in the type of search results.

I entered the following information:

Brand Name:  Clarion

Manufacturer:  Advanced Bionics

Event Type:  Malfunction

Date: 01/01/1998 to 05/12/2004

Records per Report Page:  500

The search results returned 414 records meeting these criteria,
ranging in date from 2/5/2004 to a single report in 1998, another in
1999, and just four reports in 2000.

A typical report -- which I have reproduced in full -- looks like this:


Manufacturer and User Facility Device Experience (MAUDE) Database
Brand Name CLARION 
Baseline Brand Name CLARION 
Baseline Generic Name COCHLEAR IMPLANT 
Baseline Catalogue Number NA 
Baseline Model Number MB-5100H-12 
Manufacturer (Section F)  ADVANCED BIONICS CORP. 
12740 san fernando rd. 
sylmar CA 91342  
Manufacturer (Section D)  ADVANCED BIONICS CORP. 
12740 san fernando rd. 
sylmar CA 91342  
Manufacturer Contact theresa wallace, specialist  
12740 san fernado road 
sylmar , CA 91342 
(661) 362 -1752  
Device Event Key 507265 
MDR Report Key 518227 
Event Key 491754 
Report Number 2029203-2004-00021 
Device Sequence Number 1 
Product Code MCM 
Report Source Manufacturer  
Source Type Foreign,Health Professional  
Event Type Malfunction  
Type of Report  Initial 
Report Date 02/05/2004 
1 Device Was Involved in the Event  
1 Patient Was Involved in the Event  
Date FDA Received 02/05/2004 
Is This An Adverse Event Report? No  
Is This A Product Problem Report? Yes  
Device Operator Lay User/Patient 
Device MODEL Number MB-5100H-12 
Was Device Available For Evaluation? No  
Is The Reporter A Health Professional? Yes  
Was the Report Sent to FDA? No  
Date Manufacturer Received 01/07/2004 
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer  
Date Device Manufactured 05/01/2001 
Is The Device Single Use? Yes  
Type of Device Usage Initial  

Adverse Event or Product Problem Description  
Report Date: 02/05/2004  MDR Text Key: 1788944 Patient Sequence Number: 1  
The patient reportedly was not progressing in speech production. A ct
scan (date not given) confirmed correct placement of the electrode
array. Testing performed by a company rep confirmed that three
electrodes were not functioning. Programming changes were made. In
december 2003, the patient's family members reported that the patient
removed their external headpiece and did not want to wear it. In 2004,
after a review of patient data by co reps, the recommendation was made
to explant the patient's c1 device. Surgery to explant the patient's
device has not yet been scheduled.

As you can see, the summary at the end of the record details the
actual problem, in this case, malfunctioning electrodes and overall
patient dissatisfaction with the device.

Other records report problems such as:

--poor performance
--nonfunctioning device
--incorrect voltage signal values
--programming failures

and so on.  Obviously, I cannot summarize hundreds of such reports
here, but they are available for your perusal through the MAUDE


There is other information at the FDA site that is relevant to your
question, including:

--an approval notice dated 9/9/2002 for the Clarion CII, which is
quite possibly the specific device you inquired about:
CLARIONŽ CII Bionic Ear, HiFocus Electrode without Positioner (Model
AB-5100H-11A) and HiRes Software (Model CI-6055)

Approval for the commercial distribution of the CLARION HiFocus
Electrode without the Positioner (Model AB-5100-11A) in adults with
post-lingual onset of severe-to-profound hearing loss and in children
with profound hearing loss (12-months to 17-years, 11-months of age). 
It also requested approval of the High Resolution Speech Processing
Strategy (HiRes Software, Model Number CI-6055) for both patient


The initial approval for the Clarion device in 1997:

CLARION Multi-Strategy Cochlear Implant 
This device is intended to restore a level of auditory sensation to
children with profound sensorineural deafness via electrical
stimulation of the auditory nerve. CLARION is indicated for the
following: Children, 2 through 17 years of age. If x-rays demonstrate
evidence of ossification, children as young as 18 months may be
implanted. Profound, bilateral sensorineural deafness (90dB).
Undergone or be willing to undergo a hearing aid trial with
appropriately fitted hearing aids. Lack of benefit from appropriately
fitted hearing aids. In younger children, lack of benefit with hearing
aids is defined as failure to attain back auditory milestones such as
a child's inconsistent response to his/her name in quiet or to
environmental sounds (Meaningful Auditory Integration Scale). In older
children, lack of aided benefit is defined as scoring 0% on open-set
word recognition (Phonetically Balanced Kindergarten Test - Word List)
administered with monitored live-voice (70 dB SPL). Both younger and
older children should demonstrate only minimal ability on age
appropriate open-set sentence measures and a plateau in auditory


The full notice for the approval (which is a large, 76-page PDF file) is here:


I mentioned the implants-meningitis link, which was reported in 2002. 
I realize this is not relevant to your situation, but I wanted to post
the link, just the same:
Cochlear Implants and Meningitis

The FDA is notifying health professionals about a possible association
between cochlear implants and bacterial meningitis. Cochlear implants
are devices that are permanently positioned in the inner ear of deaf
patients to help improve their hearing. The implants activate auditory
nerve fibers, allowing sound signals to be transmitted to the brain.
Several dozen cases of meningitis have occurred in patients with
cochlear implants, and twelve known deaths have occurred. Most of the
patients have been children under the age of five, but some adults
have also been affected. The time between the implant and the illness
has ranged from 24 hours to more than five years.

At this point, it's not certain whether the implants themselves are
raising the risk of meningitis, by serving as a focal point for
infection, or whether some predisposing factor might be responsible.
For example, some deaf patients may have congenital abnormalities of
the inner ear which make them more susceptible to meningitis. In other
cases, patients might have had otitis media prior to the surgery.
Nonetheless, in response to this issue, one manufacturer, Advanced
Bionics, has recalled its Clarion model cochlear implants.


A press announcement regarding the approval of the Clarion CII device
can be seen here:

Advanced Bionics Announces Approval of the High Resolution ClarionŽ
CII Bionic Ear System in the US and Canada



A good overview resource for information on problems with cochlear
implants is this site at:

Cochlear Implants - Reimplantation and Extrusion

Note from the article that the Clarion devices do not seem to be
notably different from other implants in terms of numbers of reported

Also note on the left-hand side of the page there are links to many
other articles and resources pertaining to deafness, hearing devices,


You also asked about lawsuits.  Oddly enough, there appear to be very
few lawsuits involving Advance Bionics, and none that focus on the
functioning or problems with the Clarion device.  The cases that exist
are corporate in nature, such as:

Cochlear Ltd. v. Advanced Bionics Corp.

Medtronic, Inc. v. Advanced Bionics Corp.

and involve issues of competition, confidentiality, intellectual property, etc.

I found no cases involving Advanced Bionics that dealt with the
Clarion device.  As I mentioned in my earlier remarks, it may be too
early in the device's history for cases to have fully moved through
the legal system and found their way into legal databases.

If cases do get filed, they will likely involve the meningitis issue,
as discussed in this article from Insight Magazine:

No One Listening to Meningitis Concerns
Feb. 7, 2003

"...These questions are attracting trial lawyers hoping to line up
clients for wrongful-death suits. One of the largest law firms in the
United States, Lieff Cabraser Heimann & Bernstein, has been trolling
on the Internet for cochlear-implant clients. Attorney Stephen Cassidy
says the firm has been contacted by two people, but so far there is
"no smoking gun" that implicates anyone or suggests the companies
covered up the deaths so they could continue to sell their products
for thousands of dollars. The firm has yet to file a lawsuit..."


I hope this information meets your needs.  As I mentioned earlier, if
anything here is unclear, just let me know and I'll be happy to assist
you further.

All the best.


search strategy:

Searched the MAUDE database as described.
Searched Lexis-Nexis legal databases for Adv! Bion!
Searched Google for: [ "advanced bionics" (suit OR lawsuit OR "class action") ]
Subject: Re: Medical Device Malfuncioning
From: medicaldeviceman-ga on 09 Mar 2005 18:02 PST
For a more general indication on how the FDA handles complaints you can check out:

For very specific answers to questions you have regarding Medical
Device Reporting and Recalls check this out as well:

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