Defibrilaltor Leads

Medtronic now faces lawsuits from patients who have a Sprint Fidelis lead attached to their heart and defibrillator.  Medtronic lead lawsuits are now being filed in many states, and attorneys familiar with this medtronic recall are providing counsel to these patients.  The FDA considers this to be a medical device recall and has put a warning out to patients.

Update on Lead Recall
In a statement released to the public, Medtronic advises that a voluntary marketing suspension Sprint Fidelis Defibrillator Leads has taken place.

Medtronic decided to voluntarily remove its Sprint Fidelis defibrillation leads from the market. According to adverse event reports, the electronic wires are prone to fracture and can cause the defibrillator to deliver unnecessary shocks or not operate at all.  These failures have resulted in deaths and major complications.

Patient Fear of Defect in Device
While defibrillators are life-saving products, it is scary for a patient who needs the device to monitor and correct heart rhythm abnormalities to know that there is a defect in that device that could cause serious injury.  Medtronic has admitted that it is "frightening for a patient to learn that a product they rely on so much might have a serious defect." 

Since the Sprint Fidelis defibrillation leads fractures have been detected, no more of these defective leads will be sold or manufactured and Medtronic is advising that any remaining product should be pulled from inventory and returned to the company.

Why has this taken so long?
Medtronic first notified physicians in March 2007 that there were failures.  Why only now are patients with these implanted leads being asked to contact their physicians for further information? We intend to get an answer to that question for our clients!

What went wrong?
Most implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) function fine.  They are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds put the heart back into normal rhythm by delivering a pulse of energy (electric shock) through an electrode wire or lead that is connected to the heart. 

Some of these wires have been found to have broken.  Luckily, not every wire breaks.  In fact, according to Medtronic, most leads function well. But, where a lead actually breaks, or "fractures," the lead may send false signals.  These signals can result in too many or too few shocks.
 
FDA Action
The FDA now considers this problem to be a product recall, which means that Medtronic will soon be issuing a recall classification for this action. Medtronic points out that the word "recall" does not mean that the devices must be surgically removed and returned to the manufacturer. However, the company points out in its publications that going forward these "leads should no longer be implanted in patients."

Will my wires fracture?  Is there a test?
Medtronic has advised that there is no test to predict which leads will fracture.

Should you have the wire removed?
Medtronic does not currently recommend the routine surgical removal of a fractured lead because removal carries risks. You need to discuss this with your doctor.  Your physicians can help you weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.

What if you have a defibrillator from another company?
A number of Sprint Fidelis leads are used with defibrillators made by non-Medtronic manufacturers. If you think that you have a Sprint Fidelis lead or if you do not know the model of your lead, you can contact your doctor to obtain this information.

If you or someone you know has received a defibrillator with Sprint Fidelis leads (implants since 2004) please contact our offices for a free case evaluation.

Please fill out the form below to see if you have a Sprint Fidelis Defibrillator Lead Wire case.

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* Click on the Disclaimer, below, for Terms

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PERSONAL INFORMATION

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MEDICAL INFORMATION

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Which manufacturer's device has been implanted?
What was the date you received your implant?	January February March April May June July August September October November December 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902
Which model lead wires were used?	-Please Select- Sprint Fidelis Model 6930 Sprint Fidelis Model 6931 Sprint Fidelis Model 6948 Sprint Fidelis Model 6949 Other
If 'Other' Please Specify:
Did your lead wires break or fracture?	Yes No
What complications have you had from the defibrillator leads (wires, electrodes)?
Were your lead wires replaced or capped?	Yes No
What recommendations have your doctors made about replacing these wires (leads)?
If wires replaced or implant removed, what was the date of removal or replacement of your implant or wires?
January February March April May June July August September October November December 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902
Please be specific and tell us about your experience with the Defibrillator and Leads:
Please enter any questions or comments/questions in this space: