Medtronic investigations initiated by federal government
Medtronic, Inc. has acknowledged that they are the subject of multiple federal investigations regarding their marketing practices and the recent Sprint Fidelis defibrillator lead recall. The Senate Finance Committee and the Justice Department have both asked the company for information as part of investigations of wrongdoing. They also face thousands of potential lawsuits from individuals who received one of the defective wires, which are used to connect implantable defibrillators to the heart.
It was reported yesterday in the Wall Street Journal that the global medical device manufacturer acknowledged the federal investigations as part of a filing with the SEC (Securities and Exchange Commission).
Medtronic Lead Recall
- Model 6930
- Model 6931
- Model 6948
- Model 6949
On October 15, 2007, a nationwide Medtronic recall was issued for all models of the Sprint Fidelis defibrillator lead. Defects in the lead could cause the thin electrical wire to fracture or break, resulting in electrical shock or device failure.
A lot of controversy has surrounded the approval of this device by the FDA, since no specific testing was required before it was introduced in 2004. In addition, many have expressed concerns about the timing of the defibrillator lead recall, as the Company delayed removal of the device from the market for many months, allowing thousands of people to receive the lead which was known to be dangerous and defective.
Medtronics indicates that the Senate Finance Committee has requested information regarding the defibrillator lead recall as well as information about alleged payments made to doctors by the company. Shortly after the recall, the company was also the subject of a letter from the U.S. Congressional Committee on Oversight and Government Reform, which was sent to the commissioner of the FDA inquiring about the Sprint Fidelis lead’s approval process and when the FDA first learned about the risk that the leads could fracture.
>>PRIOR POST 10/24/2007: Congress investigates Medtronic recall
A separate Medtronic investigation has been initiated by the Justice Department, through the U.S. attorney’s office for the Eastern District of Pennsylvania. The U.S. attorney requested that the company provide information about payments made to doctors outside of the United States. The alleged payments could be in violation off the U.S. Foreign Corrupt Practices Act, which is designed to prevent companies from bribing foreign government officials.
MEDTRONIC DEFIBRILLATOR LEAD LAWSUITS
Approximately 235,000 people have one of the recently recalled Sprint Fidelis leads, and many of these individuals are pursuing lawsuits to seek substantial compensation from Medtronic for what they have been put through. The lawyers at Saiontz & Kirk represent individuals who are filing Medtronic lawsuits nationwide.
Any defibrillators implanted since 2004 could have the Sprint Fidelis lead. To determine if you, a friend or family member may be impacted by the recall, contact your doctor for medical advice and contact our office for a free legal consultation.
8 Comments • Add Your Comments
Carl L. Shrum says:
Do you know about others that have suffered near and and some actual deaths caused by medtronic pain pumps implanted for the back pain issues?
My story is very long, since I have fighting against this back injury for almost 6 years now! But my most recent procedure involved my second attempt to have medtronic’s pain pump implanted in my spine area, etc. And BELIEVE me it came very, very close to killing me, and it appears as if it has caused quite of bit of damage to various other parts of my body that I will be forced to deal with for a long time to come and possible the rest of my life. Not to mention all the pain and anguish this put my entire family through and things of this nature…. Like I have said this story is much too long yet very serious, containing many many various facts, much too much for me to attempt to write here. Since this has very seriously damaged my eyesight as well as many other things as mentioned…
Posted on December 9, 2007 at 11:30 am
Austin Kirk says:
Mr. Shrum,
At this time we are not investigating any product liability lawsuits involving Medtronic Pain Pumps used for back pain. However, if you believe that a defect in the pump or a medical mistake has caused an injury, please contact our office privately for a free consultation. You can call our office directly at (800) 522-0102 or fill out the form on the right side to request a claim evaluation. We look forward to speaking with you.
Posted on December 9, 2007 at 3:11 pm
Paula McConnaha says:
I am writing in regards to the pain pumps. Back on march 22 2000 my mother died from a morphine over does. and i beleave it was do to the pump. IT had not been working right so they went in to repair it. she went home the same nite and feel asleep and never woke up. we could not find any one to take the case. I know in my heart one day there will be a big lawsuit because of these pumps. I still have my mothers. So if your thinking about getting one you better look more into them.
Posted on January 21, 2008 at 11:10 am
Leah S says:
My mother just passed away in November of 2007. She had the morphine pump for about 3 years. At one point the lead broke lose and was spraying morphine all over her body. They repositioned the lead. Then in November she went to her pain clinic complaining of nausea. They checked her pump and her lead and said everything was working properly. She then had my sister take her to an ER. She was very ill. They told her she had a common stomach virus and sent her home. She died that night in her sleep. The 1st autopsy found nothing. We are still waiting for the toxicology results to come back. We are in shock. She had just been into her Dr. and had a complete physical 2 weeks prior to her death and got a clean bill of health.
Posted on February 11, 2008 at 10:25 am
GAYLE says:
I HAVE A MORPHINE PUMP I HAVE HAD IT FOR 2 YRS. IT IS FOR MY BACK ALSO .THE MEDS HAVE BEEN CHANGED ONCE FOR NAUSEA .IT HELPED FOR A WHILE .NOW THE NAUSEA IS BACK AGAIN.AFTER MANY TESTS MY FAMILY DR.THINKS IT MAY BE FROM MY PUMP MEDICATION.BUT I HAVE HAD NO OTHER PROBLEMS.MY PAIN IS SO MUCH BETTER AFTER I HAD THE PUMP PUT IN.
Posted on September 29, 2008 at 3:49 pm
james says:
pump fliped over kinking cathater stoping meds when returned to proper position blood clot lost left leg below knee.heart attact.
Posted on March 7, 2009 at 10:38 pm
Mari says:
On Moday, June 22, 2009 I had a trial morphine pump installed. The pump malfunctioned a dumped the entire bag of morphine into my system. I gained consciusness 36 hours later and spent some time in the ER. I feel I am lucky to be alive, but am furious.
Posted on July 4, 2009 at 11:12 pm
LOWELL says:
I JUST HAD MY MORPHINE PUMP TAKEN OUT AFTER 9 YEARS
Posted on September 4, 2009 at 7:51 pm