On Monday Medtronic issued a warning about the possible fracture danger associated with a small percentage of defibrillator leads. This warning was accompanied by a voluntary stop in distribution of these allegedly defective leads. Yesterday the company updated the warning and issued a Class I Recall. The recall covers Medtronic Inc Sprint Fidelis Defibrillator Leads manufactured September of 2004 to October 15, 2007. The affected leads are from model numbers 6930, 6931, 6948, and 6949. Patients who are unsure of the model number of their implant should immediately contact their physicians for more information.
Although it is thought that the defective leads are only slightly more likely to fracture the FDA is taking no chances. In the rare occurrence of lead fracture it may send false signals resulting in inappropriate defibrillator shocks or lack of shock in necessary situations.
Doctors can insert a new lead into the vein if there is room for it, attach it to the heart, and then put a cap on the old one.
The risks of surgically removing the lead depend in part on how long it has been in place. Scar tissue forms around the lead after it is implanted. Removal can produce bleeding from torn veins and damage heart muscle. The risk of such complications ranges from 1.4 percent to 7.3 percent.
If you believe you have a defective lead we would like to hear about it.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.