Today's Debate: Is Medtronic recall good enough?

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reality show &/or 12 hr.,5 part maj. motion pic. much better!

I didn't see this tv show which you reference as a basis for speculation about this Medtronic recall situation. However, from the few words with which you provide the substantive details of its synopsis, its quite clear that its writers'regard for authenticity/realism was rigorously and strategically upheld to that same ellusive elite, puritain standard of intellectual
televison broadcast quality content by which but only a bold few programs can be compared. Gilligan's Island,I Dream Of Jeni. Bewitched and My Mother The Car...each billowing with
captivating and unseeming scientific marvellations and wonderment to stimulate the minds of young intellectuals and presented HARD REAL LIFE ISSUES and comelling events
that breed the sorts of innovative Yankee Engineering know-how and unbridled creativeity that has made the USA the world Superpower we are!

(Using a crowbar or by wiggling my nose or rubbing my Jeni lamp, I will now pry my tongue out from my cheek where its deeply embedded.)

Your article smacks of the most astounding and reckless brand of public fear-mongering
and mindless supposition which slithers beneath the belly of most gossip spinning tabloid journalism. For a seasoned journalist
whom specializes in the subjects /events of healthcare, you reveal the most shocking disregard and oblivion of the most prestigious most envied and most critcally acclaimed high standards of world class manufacturing quality assurance and ethical
integrity by which Medtronic and the FDA operate.

Its absolutely insane for someone to postulate a scenario or to pitch this so called "debate topic" over the Medtronic reall situation based upon the poorly constructed 100% fictional drama contained
in this tee-vee show which had coinciding topical elements (ie. a pacemaker manufacturer, apparent quality issues in its lead assemnblies)

TMK, never before in the history of the US medical device industry has any local D.A.,beat cop or gumshoe detective, made a solo investigation /disocvery like that which this tv show presented!!

Rather than delve in the astronomical , highly complex and technically verbose,iterative regulatory process by which class 2 and 3 "critical devices" are produced and regulated in this country or describe the vast, rigorous and impeccable Quality Assuarnace/ Product Development Organizations within Medtronic (of which I am qualifed/capable of doing as a former employee within both the Manufacturing/Quality and Prod Dev Engineering worlds of this company),let me
approach this from a far more interesting , proocative and entertaining perspective!

Entertainment...capitvating, drama filled,
gratuitious,FICTIONAL entertainment is what your article's substantive merrits are and so let me *lubricate and ENHANCE?* this article with some realism that your readers will appreciate and richly enjoy.

In order for your debate question and the TV shows storyline to be at all plausible and credible,we must first conjure/invent a fictional US company which operates outside
of the entire regulatory process. That is to say,a company which, by its products design/fucntion and its marketing, does not appear to be a medical device producer. There are lots of real life bonafide and highly successful companies who do exist and operate in precisely this fashion in order to circumvent the rigorous FDA regs for quality assurance.Currently in the US, the most lucreative and expansive industrry where we might want to place our fictional enterprise /operation is in the unregulated laisse-fair industrial jungle of the ADULT ENTERTAINMENT'S NOVELTIES/TOYS INDUSTRY.

Oooooooooo! Yaaahhhhhhh!SEX!!Nasty!!
When it comes to crafting gratutitous fictional entertainment with diabolical criminally minded corporate leaders and cascading plot twisting scandal as its
wry, routine,mundane standad operating procedures, few would argue that the ADULT
INDUSTRY moreso than any other,lends itself to our slimey corporate mission.

In a world where consumer electronics gadgetry,computer tech /telecomm tech are the insatible viable, high growth areas of the consumerism worldwide and where the proliferation of legal porn has successfully embedded itself (and in fact is embraced by) within many let areas of these markets, the time is right for
not only PERSONAL PLEASURE, SEX AIDS, SEX TOYS TECHNOLIGIES to arrive in your local electronics /computer stores but soon an
even BETTER,MORE APPEALING gadget will hit the store shelves!

(Okay,here we go folks...arriving just in time for the Christmas Holidays...

****POWER PACER PLUS?****

INTRODUCING THE MOST ADVANCED MOST POWERFUL MOST MULTIFUCNTIONAL PROGRAMMABLE PERSONAL
PLEASURE PERFORMACE PRODUCT/ CEL PHONE/ SCHEDULER/ PLANNER/PDA AND INTERNET BROWSING DEVICE DESIGNED FOR THE BABY-BOOMER-AGED MALE USER!

THIS REVOLUTIONARY DEVICE IS A TURNKEY,. LIFESTYLE REVONATING REVITIALIZING SOLUTION FOR MEN OF AGES BETWEEN 40 AND 90!!

ITS FEASTURES INCLUDE THE FOLLOWING-
-CEL PHONE
-WEBCAM
-8MPXL DIGI CAMERA
-AUTO CYNCRONIZING DAY/WEEK/MONTHLY
-PLANNER.SCHEDULER
-Bluetooth abled MALE PERFORMANCE
ELECTRO DEVICE
-Bluetooth abled FULL BODY REVITALIZER
WITH CARDIO PACING TECH WHICH THE USER
INSTALLS AND CONTROLS USING THE HANDHELD
LIGHTED KEYPAD.

MEN!...THROW AWAY THOSE LITTLE BLUE PILLS....SURF THE WWW AND ROUND UP YOUR PRIVATE COLLECTION AND CORRAL OF YOUNG NUBILE BIKINI-CLAD, CORRUPTABLE, SENSUOUS PLAYFUL AND LONELY FEMALES WHO WANT TO DATE YOU!!!!

KEEP TRACK OF YOUR HIGHLY ACTIVE and ADVENTUREOUS ADULT ENCOUNTERS, DAILY INTIMATE APPOINTMENTS,ROMANTIC ENCOUNTERS,SPONTANEOUS WHIMSICKLE FLINGS AND THOSE UNFORGETTABLE EXOTIC FANTASY TRAVEL VACATIONS THAT COMPRISE YOUR NEW PLAYBOY LIFESTYLE!!

This product, technologically speaking, is
well within the current capabilities of many
ADULT NOVELTIES INDY producers. (Most certainly any of the hundreds of producers of similar gadgets as well. But its advanced male sexual performance fucntions and cardiac pacing features place it beyond the ethical
proclivity aand market strategies of the consumer electronics indy.)

SO here we have a device that's sold and *labelled as being intended for recreational
usage ONLY and is not intended as a life sustaining or life saving cardiovascular device which is sold only by prescription by a licenced medical doctor*.

Such product labelling is a critical element in all ADULT NOVELTIES INDY-related products,
btw.


Now, we have a plausible precept by which your tv shows storyline might unfold as we've
completely circumvented any/all systemic regulatory reporting requirements. Most essential are the exhaustive and religiously maintained and managed labelling, lot number traceability requirements which is the foundation for controlling quality and ensuring recallability and accountability is in tact for all the medical device indy producers.

In closing, let me remind you that the FDA
is not some faceless, monolithic, gov.
machine burried beneath and rendered impotent by the mountians of documentation and seemingly endless cycles of review/approval investigations etc.

Whenever a class 2 or 3 critical device fails/breaks during use, the law requires that the physician notify the manufacturer
immediately. The manufacturer then must- 1)notify the FDA , 2) determine the cuase andn scope of the problem and take immediate remedial actions to PREVENT A RECURRING failutre in the field. Upon notice of device failure, the FDA dispatches an Investigator
to theh manufacturing facility to investigate the problem. In my 25+ years in the industry I've personally seen and participated in such FDA investigations. They happen literally within HOURS of an failure incident!
the FDA has all the authority of LAW ENFORCEMENT and the means necssasary to
investigate and take whatever actions are necessary to enforce the law... same as any other law enforcement agency beit local, state or federal.

No,the FDA doesn't come galloping across the prairie, leather reins in its teeth
a sixshooter in one hand, rifle in the other- both guns ablazin' with corn dodgers in its saddle bags! However ,comparatively speaking
any rogue medical company would rather host
a salty old Rooster Cogburn(John Wayne)than
a highly trained ,focused and dutiful badged FDA investigator any day I can assure you.

Medtronic is law abiding, ethically profound and good peeple...JMO.

Do your homework.

Posted by: scitt   Posted on: 10/18/07 You are currently: a Guest | Members login | Terms of Use

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