Wilmington Personal Injury Lawyer - Medtronic

Medtronic Infuse Bone Graft - Patients Beware

Jean Martin — Sat, 25 Apr 2009 05:49:00 GMT

The Medtronic Infuse Bone Graft system is a cage type system implanted into the spine which containes a protein that is capable of initiating bone growth. The Medtronic Infuse Bone Graft has FDA approval to be used in the lumbar spine - or lower back. However, it has come to light that Medtronic pushed doctors to use the Infuse Bone Graft for the cervical spine - the neck - as well, without FDA approval. This non-approved use in the cervical spine has led to numerous complications including swelling of the face and neck and trouble breathing due to restriction of the airway. Others report difficulty swallowing and speaking. Unfortunately, even though the Infuse Bone Graft is not approved for use in the cervical spine, doctors receiving financial incentives from Medtronic have continued using them for cervical spine surgeries, including cervical spine fusions.

The Wall Street Journal has reported that Medtronic is being investigated becaue of the allegations that the company gave doctors numerous incentives to use the Infuse Bone Graft. Medtronic has paid out over $40 million to settle whistleblower lawsuits by former employees who alleged that Medtronic paid doctors to use the Infuse Bone Graft off-label and other spine products manufactured by Medtronic.

When implanted into the neck, the protein used by the Infuse Bone Graft can cause bone to form in teh neck, causing breathing and swallowing to be difficult, and can cause death. Doctors should stop this off-label use of the Infuse Bone Graft system and Medtronic should be held responsible for the harm it has created.

Originally posted at InjuryBoard by Jean Martin

Removing Defective Medtronic Leads May Pose Big Risk

Jean Martin — Tue, 07 Apr 2009 09:56:15 GMT

Much has been posted about the dangers associated with the defective Medtronic Sprint Fidelis Leads. Just recently it was revealed that there are more deaths associated with this faulty lead wire than Medtronic had previously reported. Lawsuits for injuries due to malfunctioning of the Sprint Fidelis Lead wires have been dismissed on the basis of preemption - a simple meaning being that FDA approval prevents lawsuits under state tort laws.

Now to add insult to injury, the New York Times has printed a very alarming article about the difficulty in removing these lead wires. Not only have people died as a result of a malfunction of the wires, now people are dying as a result of doctors trying to extract the wires. The procedure is quite complicated and there are a few doctors who have the necessary experience to perform it. The deaths have resulted from damage to a vein or the heart during the risky procedure causing extensive bleeding. Even the physicians who have the most experience with explanting these wires are saying that the procedure presents many challenges to them.

It's really unfair that patients and their doctors have been put in this precarious position. And it's even more unfair that Medtronic might not be held accountable for their actions.

Originally posted at InjuryBoard by Jean Martin

Medtronic Pain Pumps Recalled

Jean Martin — Mon, 29 Sep 2008 13:20:09 GMT

The FDA has issued a recall for Medtronic drug pumps. The recall notice came Friday. The pumps involved are the Indura 1P Intrathecal Catheter, model 8709SC; Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. The pumps are used in patients who have spasticity related to cystic fibrosis, traumatic brain injury and multiple sclerosis and from chronic pain.

The FDA issued a Class I recall which means that there is a "reasonable probability" that the product may cause serious adverse health consequences or death. Improper connections between the implanted catheter and the pump cause the medications to leak. At least 25,000 of these pumps have been sold.

Originally posted at InjuryBoard by Jean Martin