At Medtronic, a Profit Goal for Training
By BARRY MEIER
Published: September 10, 2009
Producers of medical devices — hardware like heart pacemakers and artificial hips — have long insisted that their financial contributions to teaching hospitals are meant to educate doctors, not to develop new customers for their products. But recently disclosed internal marketing documents of Medtronic seem to suggest otherwise.

The documents, a set of slides with revenue projections, calculate how much the company could expect to get back by paying for training fellowships for doctors. It is a return on investment any corporation would envy: 200 percent. The internal marketing presentation, disclosed by an Australian newspaper, The Age, was produced in 2007 by a Medtronic division in that country that sells devices for spinal surgery. The presentation briefly describes a “Global Fellowship Program” under which Medtronic would spend $1.5 million over three years to underwrite 18 fellowships in Australia and elsewhere.    >full story

Removing Medtronic Heart Cables Is Hard Choice
By BARRY MEIER
Published: April 6, 2009

BOSTON — Pulling a medical device off the market is one thing. Removing it from the bodies of thousands of patients is a lot more complicated and dangerous. Dr. Laurence M. Epstein, a surgeon at Brigham and Women’s Hospital in Boston, specializes in extracting defibrillator cables made by Medtronic.

Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died. But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country. Click here for the full story.

Life, Death & Liability
By BARRY MEIER - New York Times
Published: February 19, 2009

On the same day last month that a federal judge in St. Paul threw out hundreds of lawsuits against the maker of a faulty heart device, a man entered a nearby hospital to have one of those flawed products surgically removed. A slender electrical cable, or lead, connects an implanted defibrillator to a patient’s heart.

The risky operation went terribly wrong. As doctors extracted the device, a thin electronic cable, from the patient’s heart, a vessel was punctured, causing extensive bleeding. The 33-year-old patient, Mark Turnidge, died two days later, leaving behind a wife and two young sons.

“They told me he had suffered massive brain damage,” said his wife, Wendy Turnidge. Click here for the full story.

Study Finds More Failure of Heart Device
By BARRY MEIER
Published: February 23, 2009

A widely used heart device recalled two years ago by Medtronic may be failing in patients at a rate significantly higher than previously known, a new report by two prominent cardiac specialists indicated.

The Medtronic device, known as the Sprint Fidelis lead, is an electrical cable that connects an implanted defibrillator to a patient’s heart. The study also indicated that the component’s failure rate might be increasing over time, a potentially troubling development for patient care. More than 235,000 people received the Sprint Fidelis leads before they were recalled, and many of those patients still have them in place. The device’s flaw, which made it prone to fracturing, caused some defibrillators to deliver unnecessary shocks to a patient’s heart or to not fire when needed to send a life-saving jolt. Click here for the full story.

The study incorporated a review of 177 patients who underwent arthroscopic shoulder surgery and found a higher incidence of cartilage damage in those who received an intra-articular pain management pump. The pain management pumps are surgically implanted to serve as a delivery system for pain medication following arthroscopic surgery.

Post Arthroscopic Glenohumeral Chondrolysis
Post arthroscopic glenohumeral chondrolysis (PAGCL) is an extremely painful medical condition characterized by postoperative deterioration of cartilage in the shoulder. Intra-articular shoulder pain management pumps deliver controlled doses of medication to the joint following arthroscopic surgery. Ironically, the pump may actually cause significantly more pain than that which it is designed to alleviate.

PAGCL is a debilitating condition because of its effect on the joints. Without cartilage, joints are not protected from friction, causing extreme pain and limited mobility. Currently, there are not a lot of options available for the treatment of cartilage deterioration like that associated with PAGCL.
PAGCL Symptoms

There are a number of common symptoms associated with the development of PAGCL that can be indicative of development of the painful condition. Some of the more common PAGCL symptoms include:

* Chronic shoulder pain
* Shoulder weakness
* Popping, clicking or grinding of the shoulder
* Shoulder stiffness
* Limited range of shoulder motion

If you have been implanted with an intra-articular shoulder pain management pump and begin to experience any of the aforementioned symptoms, you may have developed PAGCL. Symptoms typically develop between three and five months after surgery. However, it is not uncommon for symptoms to take as many as 12 months to fully develop.
Intra-Articular Pumps Linked with PAGCL

A number of commonly used intra-articulator shoulder pain management pumps have been linked with the development of PAGCL, including:

* Stryker PainPump
* Stryker PainPump Blockaid
* BREG Pain Care Infusion Pump
* Donjoy Pain Control Device
* Donjoy Accufuser Plus Pain Pump
* I-Flow On-Q PainBuster

Patients who have been treated with one of the aforementioned pumps should consult with their physician immediately to determine the best course of action.

Shoulder Pain Pump Lawsuits
If you or a loved one has been injured as a result of a defective shoulder pain pump, you may be entitled to receive compensation. Medical device manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them to the public. Failure to adequately measure the effectiveness of a given product or inform physicians and consumers about any potential problems is considered negligent and may be grounds for personal injury litigation.