May 2015

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anonymous

Guest
In May 2015 a change was made to mitigate this issue.

Unfortunately you kept selling and implanting the pre May 2015 devices in patients open till Monday morning. Fully aware that the devices could completely deplete in as little as 24 hours. 2 patients died so far.

This will get very ugly my friends.
 






anonymous said:
In May 2015 a change was made to mitigate this issue.

Unfortunately you kept selling and implanting the pre May 2015 devices in patients open till Monday morning. Fully aware that the devices could completely deplete in as little as 24 hours. 2 patients died so far.

This will get very ugly my friends.
Click to expand...
Sounds very familiar.
Recently, we reported the death of a 21-year-old patient who received a Prizm 2 DR model 1861 ICD pulse generator (Guidant, Inc) in 2001 to prevent sudden cardiac death resulting from hypertrophic cardiomyopathy.3 In March 2005, this young man experienced a witnessed arrest and could not be resuscitated. His ICD was returned to Guidant, which found that the device had failed during the delivery of a shock. The cause of failure was massive electronic damage caused by electrical overstress that occurred when a short circuit developed between a high-voltage wire and a tube used to test the housing during manufacturing (see the Figure). At the time of our patient’s death, Guidant had knowledge of 25 similar Prizm 2 DR model 1861 failures in patients, 3 of whom had required rescue defibrillation. Indeed, Guidant had first observed this mode of failure 3 years earlier, in February 2002, when 2 returned Prizm 2 DR pulse generators exhibited the same short circuiting that caused our patient’s device to fail. Guidant was sufficiently concerned about these failures that manufacturing changes were made in April and November of 2002, which allegedly prevented short circuiting. Nevertheless, Guidant chose not to inform patients or physicians about these failures or the manufacturing changes designed to prevent them. Moreover, Guidant continued to sell pulse generators that were built before the 2002 manufacturing changes. Unknowingly, therefore, we and other physicians implanted Prizm 2 DR ICDs in 2002 and 2003 that Guidant knew were prone to sudden unexpected failure.4
 






























25 failures in your post. How in any sane person's view does that compare to 841? Guidant could claim they did not know better, what is your claim? You saw fidelis hurt many pts And you saw and own riata durata hurt many patients (issuing advisory after close to 1000 failures) and yet u waited for 841 patients and 2 publications before doing anything to protect patients. If I were a patient I would want you to be punished.
 






anonymous said:
25 failures in your post. How in any sane person's view does that compare to 841? Guidant could claim they did not know better, what is your claim? You saw fidelis hurt many pts And you saw and own riata durata hurt many patients (issuing advisory after close to 1000 failures) and yet u waited for 841 patients and 2 publications before doing anything to protect patients. If I were a patient I would want you to be punished.
Click to expand...
Guidant suffered significantly for several years due to the publicity generated from Prizm 2. The situation here is identical if not more serious based on the sheer numbers. STJ acted the same way GDT did back in the early 2000's. Once you are aware of the problem the company has the obligation to notify physicians and patients of the potential issue as opposed to merely fixing the problem moving forward.
 






anonymous said:
Guidant suffered significantly for several years due to the publicity generated from Prizm 2. The situation here is identical if not more serious based on the sheer numbers. STJ acted the same way GDT did back in the early 2000's. Once you are aware of the problem the company has the obligation to notify physicians and patients of the potential issue as opposed to merely fixing the problem moving forward.
Click to expand...
They were working on the fix and still selling known faulty product and that is where they will fry. And PS: their fix is not proven.
 






anonymous said:
25 failures in your post. How in any sane person's view does that compare to 841? Guidant could claim they did not know better, what is your claim? You saw fidelis hurt many pts And you saw and own riata durata hurt many patients (issuing advisory after close to 1000 failures) and yet u waited for 841 patients and 2 publications before doing anything to protect patients. If I were a patient I would want you to be punished.
Click to expand...

Maybe I want to be punished wink wink
 


















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