Notified of event through fda report.
In this report, the patient has reported: ¿i had rheumatic fever.
I have been treated for mitral valve regurgitation throughout my adult years.
I saw a dr who diagnosed myxomatous disease with bileaflet prolapse.
He recommended surgery to repair the mitral valve.
Two months later, dr performed the surgery.
He implanted a ring.
Near the end of the procedure, while in the operation room, i suffered ventricular fibrillation and was cardioverted several times.
I also suffered damage to my left ventricle.
Before my surgery, my ejection fraction was 60% to 65%.
Immediately following surgery, my ef was 32%.
More recently, my ef was measured at 25%.
I had no lv damage before this surgery, and had no significant coronary artery disease.
My follow up car has been through my long time cardiologist.
I have had v tach since the surgery.
In 2007, i received an implanted pacemaker and defibrillator.
In the summer of 2008, i received an article about the ring, which suggested that it was not approved by the fda and was experimental.
I was not informed before my surgery that the myxo ring was not approved by the fda, or that it was new, experimental, investigational, or anything of that nature.
I was not told that the myxo ring was part of a study.
I would never have consented to the use of the myxo ring had i been told that the ring was new, untested, experimental, or anything like that.
Also dr and the staff never told me that i suffered heart damage during the 2006 surgery, although that fact is well documented in the medical records.
Dates of use: 2006-2009.
Diagnosis or reason for use: myxomatous mr.