Medtronic Pacemaker Recall

Update: Critics Increase Scrutiny of Medtronic-Researcher Ties

The cozy relationship between doctors reporting on their research and Medtronic, a medical device company paying them royalties and consulting fees, continues to be investigated by an increasing number of critics. Faultfinders question the potential influence Medtronic’s payments may have had on the investigators’ scientific judgment and their published reports.

Looking into this relationship, to mention a few, are The Milwaukee Journal Sentinel, MedPage Today, The New York Times, The Wallstreet Journal, a U.S. Senate Finance Committee, and a Senate Special Committee on Aging.

Doctors who co-authored reports on clinical studies of a bone fusion product called Infuse Bone Graft made no mention or downplayed adverse effects of using the product in spinal fusion surgery or other spinal surgeries, according to editorials and other articles in The Spine Journal. The journal devoted an entire issue to questioning the doctor-Medtronic relationship.

The doctors, 15 surgeons, failed to reveal in 13 published clinical studies any adverse reactions to Infuse and the millions of dollars they were receiving from Medtronic. Payment data indicate that some authors had associations with Medtronic valued at more than $10 million.

Other researchers were reporting side effects from the bone fusion product. “Complications and adverse events range from excess cancers and serious inflammatory reactions to fertility problems caused by retrograde ejaculation and radiating leg pain,” reports MedPage Today.

“The under-reporting of adverse events in the 13 original reports was most troublesome, Carragee and colleagues suggested,” MedPage Today reported June 28, 2011.

Eugene Carragee, M.D., is at Stanford University’s outpatient clinic in Redwood City, California. Carragee, editor-in-chief of The Spine Journal, wrote, “This risk of adverse events associated with rhBMP-2 [the Infuse product] is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications.”

The Spine Journal censured the 13 papers written by the doctors who received a median of at least $12 million to $16 million per study from Medtronic.

Update: Medtronic Notifies Physicians About Glitches in EnRhythm Pacemaker

In a letter distributed to physicians worldwide, Medtronic has reported battery-related issues in its EnRhythm and EnRhythm MRI pacemaker series. In the notice, Medtronic informs physicians to avoid replacing the device, which may put patients at risk.

Meanwhile, Medtronic is working to fix the problem through a software update expected by midyear. According to Medtronic, though the battery glitch leads to inaccurate voltage readings, this does not pose any serious health risks to patients.

Unnecessary pacemaker replacements stem from confusion about battery-voltage readings during routine exams. These readings were lower than the level tracked by the pacemakers themselves, incorrectly suggesting that the pacemaker needed to be replaced. This tracking is done to provide data for a so-called elective replacement indicator.

This is the latest glitch reported in a product manufactured by Medtronic; however, the medical device manufacturer has been subject to past recalls and safety issues associated with its other products. To learn more about faulty Medtronic products that may lead to devastating personal injury or death, please read the information below.

About Medtronic

Medtronic Inc. is one of the largest producers of medical devices in the world. Founded in 1949 in Minneapolis, Minnesota, Medtronic has grown to become immensely successful, with business spanning more than 120 countries worldwide. Medtronic’s founding partners are credited with developing and manufacturing the first wearable and implantable artificial pacemaker.

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

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

Medtronic Pacemaker Recall

A Medtronic pacemaker recall was recently issued in November of 2005 for their Medtronic Sigma Series pacemakers. A defective Medtronic pacemaker, the Sigma Series has had problems with the wiring that connects the main circuitry of the pacemaker to the device header. This defect has proven capable of causing the device to fail, leaving patients at the mercy of their heart condition.

It is estimated that 40,000 Sigma Series pacemakers have been implanted worldwide; 19 of which have had failures eliciting the Medtronic recall of the device. While it should be noted that the defective Medtronic pacemaker has not resulted in any deaths, it does pose a serious risk for all patients with implanted Sigma Series pacemakers. Of the 40,000 devices implanted worldwide, an estimated 28,000 remain in circulation (6,650 in the United States).

Heart disease, or cardiac arrest, is one of the leading causes of death in the United States, accounting for approximately 200,000 to 400,000 deaths each year. Cardiovascular medical devices, such as those designed and developed by Medtronic, are used to treat patients suffering from heart rate/rhythm abnormalities that typically result from heart trauma (heart attack).

Dowload the Medtronic Sprint Fidelis Master Complaint [PDF]

Defective Medtronic Medical Devices

The Sigma series is the latest in a line of defective Medtronic medical devices. Defective Medtronic pacemakers / pacemaker-related devices have included:

  • AT500 Pacing System – (09.15.03 Advisory)
  • Kappa 600 / 700 Dual Chamber (D, DR and VDD) – (03.15.02 Advisory)
  • Thera Implantable Pulse Generators (Models 7940/41/42/50, 8940/41/42/48) – (02.18.97 Advisory)
  • Marquis DR Model 7274 ICDs – (02.05 Advisory)
  • Maximo DR Model 7278 ICDs – (02.05 Advisory)
  • InSync Marquis Model 7277 CRT-D – (02.05 Advisory)
  • EnRhythm and EnRhythm MRI pacemakers

(To view a complete list of advisory notices relating to defective Medtronic pacemakers, ICDs and CRTs, visit the Medtronic website)

Defective devices do not always warrant recalling an entire product line. Certain defects can and are attributed to anomalies or human error. Medical device manufacturers are required to report any problems associated with the use of their products, even if seemingly insignificant. The aforementioned Medtronic Sigma Series recall occurred due to a failure rate of the device of .17% to .30% and because a device failure could lead to disastrous consequences, including patient heart failure and death.

Defective Medtronic Devices – Lawsuits

The manufacturers of medical devices are required to ensure the safety and functionality of their products before they are sold commercially. When company negligence leads to widespread defects, legal action may be warranted for those who have been injured as a result.

The law offices of Aylstock, Witkin, Kreis & Overholtz have a great deal of experience in litigation associated with personal injuries incurred as a result of defective medical devices like Medtronic pacemakers. If you or a loved one has been injured by a Medtronic pacemaker, ICD or CRT, the defective medical device lawyers of Aylstock, Witkin, Kreis & Overholtz are waiting to hear from you to discuss all available legal recourse.

More Medtronic News From Our Blog