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Medtronic Battery Problems

Modern surgical techniques have allowed small, implantable devices to save lives by correcting faulty heart rhythms that might otherwise prove fatal. Companies such as Medtronic have designed and sold thousands of pacemakers and defibrillators to aid patients with heart conditions. In the 2000s, however, Medtronic faced a firestorm of controversy over two major recalls of faulty batteries in many of these products.

  1. Pacemakers and Defibrillators

    • A pacemaker is a device that corrects an abnormally fast or slow heartbeat. Temporary pacemakers may lie outside the body, while internal pacemakers remain in the body, implanted near the collarbone. Wires called leads run from the generator unit to the heart muscle, where they transmit signals that regulate heart rate.

      An implantable cardioverter-defibrillator, or ICD, corrects an irregular heartbeat. An implanted defibrillator works similarly to a pacemaker, reacting to abnormal heart action and sending an electrical jolt to adjust the rhythm. Some ICDs can double as pacemakers.

    Medtronic Products

    • Medtronic offers a wide range of medical products. The Medtronics website lists such devices as drug pumps, heart monitors, devices used for neural stimulation and implants for coronary artery procedures. The company's co-founder, an electrical engineer who applied his skills to new technologies in heart surgery, set the tone for Medtronic as a producer of implantable defribillators and pacemakers.

    2004 Warning

    • According to the law firm Ennis & Ennis, Medtronic issued a letter to doctors in 2004 warning them that several of the company's battery-powered defibrillators and CRT-D pacemakers made before December 2003 suffered from a defect. This defect caused the internal batteries to run out of power prematurely. Monheit Law lists the affected defibrillators as the Maximo VR 7232 and DR 7278, and the Marquis VR7230 and DR 7274, adding that products running off the the defective battery could fail suddenly and with no warning, possibly causing death.

    2009 Warning

    • A Heart.org article reported on another major warning from Medtronic in September 2009 regarding the company's Concerto and Virtuoso defibrillators. A total of 6,300 of these devices suffered from battery drain problems. The article quotes a Medtronic statement that the problem posed no immediate danger to their owners because the device gives a low-battery warning three months in advance, providing adequate power levels during their remaining period of function.

    Repercussions

    • Controversy continued to create a stir around Medtronic after the company issued its warnings. Online Lawyer Source reports that patients accused Medtronic of continuing to sell the defective units even after disclosing their faults. Disgruntled customers also criticized the Food and Drug Administration--which had approved the original designs--for giving the industry too much latitude over quality control issues concerning these critical heart-supporting devices. A follow-up story from Online Lawyer Source announced that in 2007, Medtronic settled 2,682 lawsuits over the pre-2005 defects, agreeing to pay a total of $95.6 million.

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