Medtronic Concerto heart device problems identified by whistleblower

Harvey Kirk

By Harvey Kirk
Posted January 31, 2007

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A former engineer at Medtronic has openly criticized the medical device manufacturer, claiming that they failed to adequately test their new Concerto implantable heart device.  Approximately 11,000 of these heart devices have already been implanted in the United States, which raises serious concerns about any potential problems with the device.

The Medtronic Conerto is a new generation heart device which is designed to treat patients with congestive heart failure.  There are over five million people with congestive heart failure in the United States.  The device improves the timing of the patient’s heart beat, ensuring that blood is pumped out to the body’s organs.  If the device works properly, it could be credited in saving many patients’ lives. 

The Medtronic Concerto device was approved by the FDA in May 2006, and has become one of the manufacturer’s most lucrative products.  The device costs over $30,000, which does not include doctor and hospital fees associated with surgery to implant the device. 

MEDTRONIC CONERTO PROBLEMS

Christopher Fuller is an engineer who previously worked at Medtronic on the Concerto device.  He claims that he resigned from his position as a result of serious failures in how Medtronic tested and evaluated the Concerto.

According to the Wall Street Journal, concerns regarding possible failures and safety problems in the Concerto have been brought to the attention of the FDA and members of the United States Senate.  Letters indicate that Medtronic chose to ignore problems with the long-distance telemetry, which is used to remotely monitor the device and the patient.

According to the whistleblower, the product showed signs of instability which Medtronic has failed to correct before selling the devices to be implanted in patients.  He claims that Medtronic Concerto problems could prevent the circuits in the device from behaving properly and possibly lead to early battery depletion or “burn up” of other circuitry in the device.

PRIOR RECALLS HAVE LEAD TO MEDTRONIC LAWSUITS FOR VICTIMS

In recent years, Medtronic and other manufacturers have issued several recalls of defective heart devices when failures were discovered after the products were already on the market and implanted into patients.  Medtronic defibrillator lawsuits are pending across the country for thousands of users who suffered serious injuries or death as a result of battery defects in prior devices.

The product liability lawyers at Saiontz & Kirk represent victims who were injured by these previously recalled Medtronic defibrillators and pacemakers.  To determine if a particular heart device has been recalled, request a free consultation with our Medtronic recall lawyers.

The defective products news and alerts portion of this website will be updated with any future information about Medtronic Concerto problems.  To receive notification of updates, subscribe to the feed, or request updates by email.

1 Comment • Add Your Comments

  • Roberta V. says:

    I just read your article & I’m a nervous wreck. My husband had a medtronic concerto inserted on 5/21/07
    This is his 3rd defiberlator/pacemaker in about 8 years. He’s had no activity recorded when having his regular tests.
    Do we have something to worry abot now? A medtronic technician was in the room while the device was being nserted. I’m afraid to show your article to my husband because I don’t want to cause him to worry constantly about something happening. What do we do?
    Thank You

    Posted on June 4, 2007 at 9:14 pm

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