Medtronic Cardiac Defibrillator Lawsuit

On February 10, 2005, Medtronic Inc. issued an alert to doctors about its family of Implantable Cardioverter Defibrillators (ICD) and CRT-D devices with batteries manufactured prior to December 2003. These pacemaker-like devices may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, battery depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

These automated devices, used by patients who suffer from an irregular heartbeat, are surgically implanted under the collarbone and emit an electrical shock to jolt the heart back into regular rhythm.

To date, Medtronic has found this battery defect in several of its 87,000 devices. Thousands of patients throughout the world rely on these defibrillators, about 75% of Medtronic's defibrillators are implanted in U.S. patients and 13,000 have already had the device surgically removed. Currently, Medtronic is offering to replace the $20,000 device and pay several thousands of dollars in additional expenses but there are no definite plans to pay for the necessary second surgery.

The devices that have been affected include the following which were manufactured between April 2001 and December 2003:

  • Marquis™ VR/DR
  • Maximo™ VR/DR ICDs
  • InSync I/II/III Marquis™
  • InSync III Protect™ CRT-D


  • In a similar situation, Medtronic recalled and replaced over 16,000 Implanted Defibrillators between 2001 and 2003 when it was discovered that a battery flaw might render the unit ineffective. In 2004, Medtronic announced a recall of their Micro Jewell II and GEM DR ICDs.

    Medtronic, a key player in the worldwide medical technology race, distributes products and services to 5 million patients each year, generating $9 billion in annual sales.

    Medical professionals advise that if you have a Medtronic defibrillator device implanted, talk to your doctor as soon as possible to find out more about your medical options.

    Medtronic Sprint Fidelis

    On October 15, 2007 Medtronic Inc. suspended sales of a component used with its implantable cardioverter difibrillators (ICD). The equipment was reportedly linked to five patient deaths. Medtronic stopped sales of the Sprint Fidelis line of leads, which link the heart to the ICD. There are nearly 268,000 leads implanted in patients around the world. The company and the FDA recommend patients see their doctors to reprogram their ICDs to better monitor for the potential of lead fracturing.

    Medtronic Products

    Medtronic Inc. is one of the largest manufacturers of medical devices in the world. Medtronic's founding partners (Earl Bakken and Palmer Hermundslie) were responsible for the development and manufacture of the first wearable and implantable artificial pacemaker.

    Cardiac rhythm management (CRM) is one of Medtronic's signature business lines, with devices that include:

    • Implantable pacemakers / defibrillators
    • Cardiac ablation catheters
    • Monitoring and diagnostic devices
    • Cardiac resynchronization devices

    Medtronic Pacemakers

    The body contains "natural pacemakers" that are responsible for regulating the beating of the heart. Severe heart trauma, such as that associated with cardiac arrest (heart attack), can neutralize "natural pacemakers," putting a person at risk of heart failure caused as a result of a slower-than-normal heart rate, faster-than-normal heart rate or irregular beating pattern.

    "Artificial pacemakers," first developed by Medtronic Inc., are small battery-operated devices that serve as replacements for "natural pacemakers." "Artificial pacemakers" are for those who have suffered a heart trauma of some kind. Medtronic pacemakers are separated into six different device categories:

    • EnPulse pulse generators
    • AT500 pulse generators
    • Kappa pulse generators
    • Sigma pulse generators
    • Thera pulse generators
    • Others
      • Preva, Prevail and Prodigy are a few of the other Medtronic pacemaker product lines.

    Although defective Medtronic pacemakers have been relatively few in number, they pose a serious health risk to any person implanted with a defective Medtronic pacemaker. In order to counter any potential health hazards, a Medtronic pacemaker recall is issued whenever a defect is viewed to be on a large enough scale. A recent Medtronic recall (Nov. 29th, 2005) has revolved around the Sigma Series pulse generators because of the device's higher-than-expected failure rate.

    Medtronic ICDs

    An implantable cardioverter defibrillator (ICD) is a type of electronic medical device that is implanted in the body of people suffering from a faster-than-normal heart rate (tachycardia). When tachycardia sufferers experience a faster-than-normal heart rate, the ICD delivers a mild shock to the heart, redirecting its rhythm to a normal beating pattern. ICDs can also help people suffering from an irregular heart rhythm (ventricular fibrillation - VF). When ICD devices detect VF, they send electronic impulses to the heart to restore its rhythm to a normal level.

    ICD units can help to reduce a person's chance of cardiac arrest. Medtronic ICDs are separated into five different model categories:

    • GEM ICDs
    • Jewel ICDs
    • Micro Jewel ICDs
    • Marquis ICDs
    • Maximo ICDs

    Like Medtronic pacemakers, Medtronic ICDs have had defects that have forced the company to issue a variety of safety advisories for patients using their ICD devices. Recent advisories (2004 and 2005) have revolved around the Marquis ICDs and the Micro Jewell ICDs. In both cases, the defects revolved around defective batteries and the inability of the device to provide a full energy shock if necessary.

    Medtronic CRT

    Cardiac resynchronization therapy (CRT) is a type of medical device designed for use by people who have suffered moderate to severe heart failure and also suffer from ventricular dysynchrony, a condition by which the lower chambers of the heart beat at a different rate (affecting 30% of all moderate to severe heart failure patients). CRT devices build on some of the technologies used in pacemakers and ICDs to re-coordinate the beating of the left and right ventricles of the heart.

    There are a number of Medtronic CRTs available, all of which fall into the InSync model category. Medtronic products have had defective CRT issues that are similar in nature to those affecting Medtronic ICD devices. Battery short issues can severely inhibit the devices ability to function, putting patients' lives at risk.




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