Subpoena over Faulty ICD's

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Anonymous

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Department of Health and Human Services wants a cut of the action, ouch! Looks like your transgressions are, again, catching up with your false claims of improved quality. Whatever happened to your corporate agreement letter with the government? Have you not learned from your myopic view of profit first, patient safety a distant second...
 












Anonymous said:
Department of Health and Human Services wants a cut of the action, ouch! Looks like your transgressions are, again, catching up with your false claims of improved quality. Whatever happened to your corporate agreement letter with the government? Have you not learned from your myopic view of profit first, patient safety a distant second...
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a bit of a stretch, even for an anonymous CP board
 






Anonymous said:
What's going on with this. Does anyone know?
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BSX rushed these cans to the market in hurry, naturally there were design faults and lack of validation and verifications. BSX also had bad header screws, seals and header itself.

It appears that the faulty header was not glued well so it started dislodging from the can.

Perhaps BSX may have repaired huge number of stock cans and sold them to the market. I am not sure about this but remember to have seen some posts here.

The truth will come out and BSX still need to learn the lessions I suppose.
 
























There are countless 'failed' leads from all vendors but until somebody like B. Meier gets a hold of a story because they have a personal connection to a tragic event nothing will happen. A failed lead(s) is much different than a full blown recall. Not until everyone puts consistent long term and unbiased data into registries will we truly know the good and bad in terms of performance and failure.
 












Anonymous said:
There are countless 'failed' leads from all vendors but until somebody like B. Meier gets a hold of a story because they have a personal connection to a tragic event nothing will happen. A failed lead(s) is much different than a full blown recall. Not until everyone puts consistent long term and unbiased data into registries will we truly know the good and bad in terms of performance and failure.
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Take a look:

http://trusted.md/feed/items/system/2009/03/25/boston_scientifics_new_icds_have_glitch

Later the set screws could not hold the lead, headers were not properly glued to the cans etc. etc.
 


















Yep, they have cleaned things right up:

Thu May 8, 2014 11:42pm EDT

(Reuters) - Medical device maker Boston Scientific Corp said it received a subpoena this week from the Department of Health and Human Services seeking information about the performance of some of its implanted defibrillators.

The subpoena, received on May 5, requested information related to the 2008 launch of two brands of implanted cardioverter defibrillators made by Boston Scientific, the company said in a regulatory filing on Thursday.

Implantable cardioverter defibrillators, or ICDs, treat arrhythmias by shocking a dangerously racing heartbeat back into a normal rhythm.

The subpoena was issued by the Office of the Inspector General of the HHS, which is responsible for identifying fraud and waste in government health programs such as the Medicare and Medicaid.

Boston Scientific, which competes with Medtronic Inc and St. Jude Medical Inc in selling ICDs, said it is cooperating with the request.

The industry has come under increased scrutiny in recent years for allegedly using kickbacks to gain market share and increase the use of their devices among physicians.

Earlier this week, St. Jude Medical said it received a civil investigative demand from the U.S. Department of Justice in April related to its cardiac devices.

The Justice Department is investigating if St. Jude paid inducements to health care providers in exchange for implanting its devices, the company said in a filing this week.

Last October, Boston Scientific agreed to pay $30 million to settle Department of Justice allegations that the Guidant unit it acquired in 2006 knowingly sold defective heart devices implanted in Medicare patients.
 


















Anonymous said:
Hey idiot -- that article was from...wait for it.... 5 YEARS AGO! You obviously have no idea what you are talking about.
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Hey it is you who has no idea, if you hide dirt with flowers, it still smells foul. You guys have hidden your glaring mistakes, repaired sub-standard drvices and sold them.

You are caught now!
 






Anonymous said:
Yep, they have cleaned things right up:

Thu May 8, 2014 11:42pm EDT

(Reuters) - Medical device maker Boston Scientific Corp said it received a subpoena this week from the Department of Health and Human Services seeking information about the performance of some of its implanted defibrillators.

Last October, Boston Scientific agreed to pay $30 million to settle Department of Justice allegations that the Guidant unit it acquired in 2006 knowingly sold defective heart devices implanted in Medicare patients.
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May be another $30 million or even more to settle the matter in this year October?
 






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