Class I recall issued on Medtronic SynchroMed drug infusion pumps

Class I recall issued on Medtronic SynchroMed drug infusion pumpsA Class I recall has been issued on Medtronic’s SynchroMed II drug infusion pumps.

The recall was deemed necessary after the manufacturer admitted that the motor can stall on the devices, especially when they’re used to dispense unapproved drug treatments. The recall includes SynchroMed II infusion pumps manufactured from May 1998 until November 2012. They were distributed from April 1999 until November 2012.

A Class I recall from the Food and Drug Administration means that use of a medical device or drug will likely result in serious injuries or death.

The recall includes the following SynchroMed drug infusion pumps: SynchroMed II, models 8637-40 and 8637-20 (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir sizes.) and the SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. [Read more...]

Judge Dismisses Medtronic’s Preemption Claim in Off-Label Lawsuit

Judge Dismisses Medtronic’s Preemption Claim in Off-Label LawsuitOverview: A California judge has denied Medtronic’s attempt to pursue litigation without a trial based on preemption in a case alleging Medtronic promoted the off-label use of its bone growth product, Infuse. The off-label use and marketing of Infuse has been surrounding the controversial product since 2008.

 

 

 

  • The California Health Department is investigating a Pomona Valley Hospital following accusations of off-label promotion and experimental procedures with Medtronic Infuse and two Stryker products
  • Judge Michael Linfield has denied Medtronic’s motion for summary judgment on the basis of preemption, stating that the plaintiff is suing on the count of federal, not state, violations
  • Medtronic has been faced with a number of lawsuits alleging it promoted the off-label use of Infuse, which has been associated with life-threatening complications

Product: Medtronic Infuse Bone Graft

Manufacturer: Medtronic, Inc.

Side Effects & Complications

  • Cancer
  • Difficulty breathing, swallowing
  • Uncontrolled bone growth
  • Nerve injury
  • Male sterility
  • Retrograde ejaculation

[Read more...]

Medtronic Infuse is Associated with Pain and Nerve Injury

Pain and nerve injury are among the side effects associated with Medtronic Infuse, which is a product used to stimulate bone growth in the spine. The U.S. Food and Drug Administration (FDA) has only approved it for certain regions of the spine (L4 to S1) and certain dental procedures, but the product has been used in an “off-label” manner, meaning that doctors use Infuse in ways not approved by the FDA. While physicians are allowed to do this, it is illegal for companies to promote off-label use.

Allegedly, Medtronic not only promoted Infuse for off-label procedures but reports suggest that the company paid doctors to hide the side effects. Medtronic Infuse has been linked to pain and nerve injury due to the excessive bone growth that occurs when the product is used. Research has also linked the artificial bone graft to male sterility, retrograde ejaculation and cancer.

National Law Firm Cautions Spinal Fusion Patients about Controversial Medtronic Infuse Bone Graft

National Law Firm Cautions Spinal Fusion Patients about Controversial Medtronic Infuse Bone GraftOverview: Parker Waichman LLP, a national personal injury firm, is warning spinal fusion patients about Medtronic Infuse Bone Graft. In a press release issued today, the firm said that patients should contact their surgeons to find out if the product was used. Medtronic Infuse is an artificial bone graft that has been linked to a number of complications, including cancer, male sterility and nerve damage. The product came under fire when Medtronic was accused of promoting off-label use and paying doctors to hide these side effects.

  • Parker Waichman advises spinal fusion patients to contact their surgeons to find out whether or not they used Medtronic Infuse
  • Medtronic infuse is approved to stimulate bone growth in the lower spine, but it has been used in the cervical and other unapproved areas; the FDA has warned that this off-label use can result in fatal complications
  • Last June, the Spine Journal dedicated an entire issue to exposing the side effects associated with this product, suggesting that industry-sponsored research underestimates serious complications

Product: Medtronic Infuse Bone Graft

Manufacturer: Medtronic, Inc.

Side Effects & Complications

  • Cancer
  • Difficulty breathing, swallowing
  • Uncontrolled bone growth
  • Nerve injury
  • Male sterility
  • Retrograde ejaculation

[Read more...]

Degenerative Disc Disease Treated with Artificial Bone Graft

Degenerative disc disease is a condition where the spinal discs between the vertebrae begin to shrink, typically due to aging. According to WebMD, these discs are meant to act as shock absorbers, which allow it move, twist and bend. Although degenerative disc disease can affect any part of the spine, it usually occurs in the lumbar (lower back) or cervical (neck) region. Patients who suffer from this condition may experience neck or back pain.

Medtronic infuse, which is a type of artificial bone graft, has been used to treat degenerative disc disease. Infuse uses a liquid bone protein in order to stimulate growth. Initially, this product seemed innovative. But after reports of serious complications and marketing scandals, the device has become controversial. [Read more...]