Re: The Sorry State of the FDA Cochlear Implant Website - A Timeline of Failure

[Guest guest]

Hi Bob, Can you tell me where I can get the information on the MED-EL

recall. I searched the MEDEL website and found nothing. Thanks

>>

> Did not mention the recall of the Med-El Combi 40+ ..Or that it had

been replaced by the new Pulsar CI100

>

>> Bob

>

>

[Guest guest]

No problemo, ! The FDA recall of the Med-El Combi 40+ never did

appear on their website. So don't feel bad! <G>

Here's the chronology:

An official Warning Letter was issued 11/16/2004

http://www.fda.gov/foi/warning_letters/g5089d.htm

An Import Block was issued 12/17/2004

Hope that helped.

Bob

> >>

> > Did not mention the recall of the Med-El Combi 40+ ..Or that it had

> been replaced by the new Pulsar CI100

> >

> >> Bob

> >

> >

>

[Guest guest]

Hi Bob & -

Actually the FDA website is not missing anything because there was

never a product recall of the Med-El Combi 40+, only an import

detention which was not due to product reliability. The Combi 40+

was also not " replaced " by the Pulsar system but rather upgraded to

the Pulsar much like the Freedom was an upgrade of the 3G.

I hope this clears up this issue for you and let me know if you have

any other questions.

Pam

CI hear moderator

Med-El 6/02

> > >>

> > > Did not mention the recall of the Med-El Combi 40+ ..Or that it

had

> > been replaced by the new Pulsar CI100

> > >

> > >> Bob

> > >

> > >

> >

>

[Guest guest]

I've been reading this list on the sidelines (over the shoulders??)

for quite some time, and as much as I've not wanted to join the ranks

of those who incite riots, frankly there's a few things that just

burn my britches.

o:

Did you even read and Pam's posting or any of the other

postings related to the Med-El product detention these past few

months?? It would appear with your intelligence and capacity for

exactness there seems an unwillingness to address a fundamental fact:

1) RECALL = (v.)1. To ask or order to return.

2. To summon back to awareness of or concern with the subject or

situation at hand.

3. To request return of a product that has been identified as

defective to the manufacturer, as for necessary repairs or

adjustments.

2) DETENTION = (v.) 1. The act of detaining or holding back.

2. (n.) The state of being detained; esp A period of temporary

custody.

3. Delay.

3) HERMETICITY = (n.) 1. Perfectly closed or sealed so as to be

airtight. closed, sealed, shut, airtight, watertight.

" Hermeticity " ?? The question and this issue has been thrown around

for MONTHS as it relates to Med-El receiving a delay imposed by the

FDA due to paperwork inconsistencies is due to hermeticity??

Common . People are on this list (additionally) to learn about

the facts about CI's as best they can so they may make an informed

and educated decision regarding a life long procedure. One they hope

will improve their lives with minimal negative impact. And a much

larger decision than buying your next car.

Your willingness to cut and paste the actual product DETENTION letter

from the FDA suggests you should have actually read it!

In short simple terminology the letter states this:

- The FDA noted that Med-El made a product design improvement [which

personally I thought was a good thing for a company to accomplish]

but Med-El had not provided a satisfactory document paper-trail for

the design change. Yes, a design change to improve

product 'hermeticity', but not due to product deficiency or patient

endangerment. Remember, the original design was FDA Approved!

- The FDA imposed a product DETENTION (read: DELAY) preventing those

units outside the United States from being delivered until Med-El

provided the required documentation for the design changes.

The FDA wanted the paper-trail for the technical improvements in the

design changes, not because of any suggested failures you elude to.

- The FDA, upon receiving the requested documentation reinstated the

product import availability.

Quite simply, the FDA did NOT prevent any implantation of any Med-El

devices still inside the United States! People still received Med-El

implantations during this entire period. It wasn't a Product issue,

it was a PAPER issue. Furthermore, and more importantly, the FDA did

NOT require Med-El to RECALL any devices from any medical

establishment or any patient for repair or replacement! Your usage

of the term " Recall " these past months [and your lack of correction

moreso] is inaccurate, deceitful, and misleading to those people who

come to this list looking for open honest information regarding the

manufacturers of CI's.

Your response to and Pam suggests that the FDA cited Med-El

because of 'hermeticity' issues! Errors such as this are just plain

MEAN. As a Father and CI supporter I find that presentations such as

this cause more harm for more people looking for straight honest

information when it's so obviously bent and shaped for some other

personal motive. I've seen you plug all the manufacturers both

positively and negatively, so I cannot presume your motives. But

I've seen you harrass Med-El excessively with mis-stated 'facts' that

just have no foundation.

" All is well now " - " Let's move on " ???? After the cut-n-paste

diatribe regarding the supposed 'hermeticity' issue you obviously

cannot move on without one last mis-representation of the facts.

Having NOW stated the facts, I agree. NOW lets move on.

Mark

Father,

CI Supporter,

Nucleus 3G

> >> > >>

> >> > > Did not mention the recall of the Med-El Combi 40+ ..Or that

it

> > had

> >> > been replaced by the new Pulsar CI100

> >> > >

> >> > >> Bob

> >> > >

> >> > >

> >> >

> >>

> >

> >

> >

> >

> >

> >

> >

> >