Defibrillator Lead Wires

The FDA has stepped in and designated a recall of Medtronic 6930, Medtronic 6931, Medtronic 6948, Medtronic 6949 Sprint Fidelis leads for Medtronic implanted heart devices.  And FDA notice has been sent regarding these medical devices and the FDA has classified this as a product recall.

On October 15, 2007, the FDA issues a Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads.

According to Daniel Schultz, M.D., the director of the Center for Devices and Radiological Health, "Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety."

The wires at issue are for the following Medtronic Leads:
Medtronic Sprint Fidelis 6930,
Medtronic Sprint Fidelis 6931,
Medtronic Sprint Fidelis 6948,
Medtronic Sprint Fidelis 6949

Dr. Schultz continues, "These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured."

According to the press release, "Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should 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."

FDA Action
As a result of the lead wire problems, the FDA will monitor information about the devices and take action as necessary.

Hire a Lawyer!
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: