Medtronic Infuse bone graft lawsuits aren’t the only things medical device manufacturer Medtronic should be worried about. The FDA recently issued a Class I recall of two Medtronic infusion pumps, due to motor failure when the pumps were used with drugs not specifically approved for them.

The FDA recalled the SynchroMed II Implantable and SynchroMed EL Implantable infusion pumps. The pumps may stall intermittently or permanently during drug delivery during use with non-approved drugs, leading to severe adverse effects and death. In addition, the company will continue to investigate motor gear corrosion, which contributes to permanent motor stall.

According to an advisory letter Medtronic sent to doctors, the failure rate associated with the device went from 2.4 percent used with approved drugs to 7 percent with unapproved drugs. The company advised against using compounded drugs, unapproved concentrations and unapproved formulations with the recalled SynchroMed pumps.

Medtronic Infuse Bone Graft Off-Label Use Causes Adverse Effects

Another Medtronic product, the Infuse bone growth protein used in spine surgery, has also been linked to serious adverse effects, especially when used in off-label procedures. Medtronic Infuse bone graft side effects can include:

  • compression of the airway, resulting in difficulty in breathing and swallowing;
  • respiratory depression
  • nerve damage (causing pain and tingling in neck, legs, etc.)
  • death.

In 2008, the FDA issued an alert about Medtronic Infuse off-label use side effects, stating “that the safety and effectiveness of the rhBMP in the cervical spine have not been demonstrated and these products are not approved by the FDA for this use.”

The Agency has received 280 reports of Medtronic Infuse side effects, about three-quarters of which involved off-label use. A 2011 Spine Journal investigation into the risks associated with the rhBMP used in the Medtronic Infuse found that 13 Medtronic funded studies downplayed or failed to report Medtronic Infuse safety issues.

Medtronic Infuse Lawsuits Filed By Injured Patients

Patients who received the Medtronic Infuse bone graft during surgery and suffered complications are filing lawsuits against the manufacturer to seek compensation for their injuries. Medtronic Infuse lawsuits allege that the company widely promoted the use of Medtronic Infuse in off-label procedures despite the elevated risks of adverse effects and death.

To learn more about how to file a Medtronic Infuse bone graft lawsuits and seek compensation for your medical expenses, lost wages, pain and suffering, and more, call (877) 779-1414.

Published December 27, 2012 by