Defective Defibrillator Leads
medtronic‘s sprint fidelis leads have been recalled due to serious safety concerns
The Sprint Fidelis lead is a wire that runs through a blood vessel and attaches a defibrillator to the heart. The lead wire is usually one of the more fragile components of a defibrillator, but a defective design may be the cause of the alarming rate of failure associated with the Sprint Fidelis lead.
The implantable defibrillators are designed to continuously monitor the heart and if a dangerous heart rate is detected an electrical signal is sent to correct it. However, if the lead from the defibrillator to the heart is broken or fractured, the signal may never reach the heart.
defective lead recall information
On October 15, 2007, Medtronic suspended sale of their Sprint Fidelis Defibrillator leads (Models 6930, 6931, 6948, 6949) after receiving reports of 5 fatalities.
According to Medtronic, since 2004 over 268,000 patients in the United States have been implanted with the defective lead as part of the defibrillator.
Medtronic estimates that as many as 4,000 – 5,000 people implanted with defective Sprint Fidelis lead will experience a lead fracture within 30 months of the defibrillator implant.
Medtronic has offered to pay for the replacement of fractured leads and $800 towards the replacement surgery, however, they will not voluntarily compensate patients who wish to replace a “working” lead.
All patients who received a Medtronic defibrillator since 2004 are urged to visit their doctor to check for possible lead fractures.
A lead fracture can result in the defibrillator misreading a healthy heart rhythm. This could potentially cause the defibrillator to send an unnecessary, painful shock to the patient’s heart, or worse, it could fail to send a vital life-saving shock.
One decision facing doctors and patients is whether to remove the lead wire, a procedure that carries some risks, or leave it in place alongside a replacement.
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