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In an article on Mass Device’s newsletter of March 6, 2012, Dr. Robert Hauser is quoted as saying, "Patients in the U.S. continue to be exposed to under-performing and potentially hazardous medical devices after they have been approved by the FDA."[1] Hauser is one of the physicians at the Minneapolis Heart Institute who drew attention to problems with the Guidant pacemakers when a patient he was treating died. Guidant recalled 132,000 of its pacemakers in 2005-6 that had a problem with the pacemaker’s hermetic seal which could fail disrupting the power supply, so that the patient’s heart would not be stimulated to beat.

Hauser indicated that the problems with St. Jude Medical's Riata defibrillator leads, now recalled, might have been caught sooner if it hadn’t been for sluggish policies and practices of the FDA. In an article for The New England Journal of Medicine, Hauser noted that problems with the leads, which are implanted in approximately 79,000 patients in the U.S., were not discovered for a protracted period of time, due to "lax post-market surveillance." Hauser also noted that St. Jude couldn’t detect the defects in the defibrillator leads "until they had already affected thousands of patients."

The FDA recalled the Riata leads in December 2011 although St. Jude had stopped selling the leads in 2009 due to having received increasing reports of patients experiencing insulation abrasion (when the coating on the lead wire fails to cover the lead). St. Jude’s chief medical officer, Mark Carlson, said, "St. Jude’s has a strong history of product safety and reliability," and noted St. Jude will continue to be committed to developing technology and products that save and improve the lives of their patients.

When a patient is meeting with his or her physician prior to surgery, or in the operating room and about to receive a pacemaker or defibrillator, should he or she be asking their doctor before they are anesthetized, "By the way, has this device been thoroughly checked for safety?" Certainly, every patient doesn't have that opportunity –and one would like to believe that whatever device is being installed or implanted actually has been thoroughly tested and in fact works.

4 Comments

  1. Gravatar for Zap Talker

    When a patient is in the emergency operating room and about to receive a pacemaker or defibrillator, should he or she be asking their doctor before they are anesthetized, "By the way, has this device been thoroughly checked for safety?"

    There is NEVER a circumstance where a patient is being implanted with a defibrillator emergently. All questions can be asked prior to the elective procedure. And physicians implant that which FDA deems safe. They don't knowingly implant something that is "bad". Checking facts before posting to the web is generally a beneficial practice.

  2. Gravatar for Greg Webb

    Mr. Zap Talker:

    Thank you for reading this blog. Despite my inartful prose, it appears the point was made. Delete "emergency". I thought I took that out. And, I never indicated that a physician would knowingly implant a defective device like this. To the contrary, I think physicians are sometimes misled by the manufacturers.

    Greg

  3. Gravatar for Jim Mitchell

    I have an RVA 1581/60 lead implanted in 2004. There was no doctor advice, discussion or disclaimer that the equipment, a St. Jude ICD or its ancillary parts might be subject to failure or deterioration at a later date.

    Now, I have been advised by medical personnel that it is extremely dangerous to remove this lead by way of laser surgery because the lead can snag on the heart. Moreover, another heart surgeon advised that when implanting these leads into the side of your heart, there is only one "sweet spot" chosen where the lead can make best electrical connection with the ventricle it is protecting with a potential electrical jolt of what is pedestrianly called "therpy" by the electrophisiology community.

    I've got this lead inside me. When the insulation peels off or deteriorates, what is going to happen? Does it represent a dead short to your heart wherein one might die in a similar fashion as a lifer sitting atop Old Sparky? The company that made and or used this particular lead are not forth-coming with answers to patients like me who only desire to know the bottom line, short and sweet. Has the cure now become more fatal than the V-tach for which the ICD was installed to prevent? Please, St. Jude, talk to the community, disseminate some light into the darkness and provide patients like myself with the security of the plain truth.

  4. Gravatar for Gail Stackman

    Is this like the Bridgestone tire expose? Will we only find out the real statistics when the death rate exceeds hundreds?

    Is it better to have the questionable combination of a St Judes defibrillator and Riata leeds that might or might not work or might perhaps cause serious problems or death???? Is replacement a greater risk? My original Defib. was Medtronics or Guidant. Does this present any greater risk? There are few answers to the game played by the medical world whose bottom line is profit. This is just one more nail in the public coffin!

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