MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC'S BONE MORPHOGENETIC PROTEIN, INFUSE

Device Problem Off-Label Use (1494)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Stenosis (2263); Disability (2371); Ambulation Difficulties (2544)

Event Type  Other  

Event Description

Hi, my name is (b)(6) and i know that you have a huge responsibility trying to protect the american citizen.I wish you well in your endeavors.I wish to speak to you about an issue that was taken up by the (b)(6) last year.It is the off label use of medtronic's bone morphogenetic protein, infuse.This is a bio engineered substance applied to a sponge, inserted into a cage and supposed to be implanted through an anterior incision into 1 level of the lumbar spine.It is fda approved for this only.(b)(6).They set out to persuade other surgeons that using infuse off label, even though much more expensive, was a better choice than the patient's own bone, or a donor bone in spinal fusion.In fact, the exact opposite is true.The substance causes excessive bone growth, causing stenosis and the nerves to be impinged through out the entire back.Infuse also causes inflammatory reaction causing excruciating nerve pain.It caused retrograde ejaculation and sterility in men.When used in cervical fusions, it caused swelling, sometimes causing breathing problems, needing intubation, and immediate removal of the infuse.It has caused death.Because of the accelerated bio growth material, leaking from the cage, cancer rates in patients who have received infuse are estimated to be higher, especially prostate, kidney, pancreatic, breast and colon cancers.(b)(6) did fine medtronic (b)(6) dollars and shareholders received (b)(6) dollars due to their malpractice.Humana is now suing medtronic for fraud.The literature has found that spinal fusion occurs just as well with donor bone or a patient's own bone, and not the expensive infuse.As you well know, many of us have had this implanted off label in our backs with devastating, life altering, consequences.I had the surgery off label in 2012.Since then, i am in intractable pain.I have radiculopathy in both legs from l1 to s2, and bone growth causing severe central and lateral recess stenosis throughout my whole back.I can walk about 1/2 a block like a 90 year old, using a caine.I go to mass and a store and come home in tears with pain.I am basically home bound.I can't drive anymore.One or two steps is like the grand canyon.I offer it up.Naturally, i am so afraid of any more surgery.I rely on my catholic faith.I am (b)(6).But, many of the patients who received this infuse are young men and women with their whole lives ahead of them.The government received their money.The shareholders were compensated.The insurance companies are going to recover their money.But, unfortunately, due to preemption, the patients, whose lives are ruined by infuse, are not going to receive a penny.Is it possible to look into the language of the fda's approval of infuse and make a warning regarding off label use? it is so unjust that the people whose lives are ruined will never see their day in court.Thank you very much.(b)(6).Message sent: (b)(6) 2014, 2:09 am.

• Brand Name: MEDTRONIC'S BONE MORPHOGENETIC PROTEIN, INFUSE
• Type of Device: MEDTRONIC'S BONE MORPHOGENETIC PROTEIN, INFUSE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4102777
• MDR Text Key: 4839855
• Report Number: MW5038240
• Device Sequence Number: 1
• Product Code: NEK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2014
• Patient Sequence Number: 1
• Patient Age: 62 YR