On October 15, 2007, Medtronic, Inc. in Seattle, issued a warning about possible danger from a small percentage of its defibrillator leads. It asked physicians not to use a faulty wire that is attached to its heart defibrillator because of the chance it may fracture or crack. It suspended sales of this lead.
This lead is situated inside a vein traveling to the heart. The purpose of a defibrillator is to keep the patient’s heartbeat regular, preventing ventricular fibrillation (fast and ineffective beating). It is implanted near the shoulder and has wires running to the heart. Some people wear pacemakers without defibrillators, and such people are not at risk.
The lead is one of a family of leads called Sprint Fidelis and the relevant model numbers are 6930, 6931, and 6949, manufactured between September, 2004 and October 14, 2007. It has been used in about 60% of Medtronic defibrillator implants.
If it were to fracture, three things might happen:
- It could beep, warning the patient to contact his doctor immediately – this would not be a problem
- It could give a large electrical shock to the chest – which would feel enormously uncomfortable and could be fatal
- It could deplete the defibrillator battery – which would prevent the device from giving a potentially necessary shock to the heart
As of October 15, five patients have died, possibly because of this flaw in the lead. Approximately 235,000 patients have these leads in their chests and Medtronic estimates that 2.3% of them (4,000 to 5,000 people) could suffer from a lead fracture within 30 months of the wire being implanted. The company will be sending letters to all Sprint Fidelis patients to warn them of the risk and asking them to go for computerized testing of the wires attached to their defibrillator.
Deciding whether to remove the wires
There is risk to removing the leads. When they are implanted the body forms scar tissue around them. Removing them can cause bleeding from the veins and damage to the heart muscle. One alternative to removing them could be to insert a new one in the same vein, if it can be fitted in, and to cap off the old one. Another alternative offered by Medtronic is to reprogram the defibrillator to beep if the lead breaks.
The scar tissue grows around them gradually. If the leads have been in place for six months or less, they could be removed fairly easily. If they have been in for two years or more however, the risk is greater.
There is always some degree of risk in having an implanted defibrillator and all patients would be informed of this at the time of the procedure. There could be infection or malfunction of defibrillator leads, or some other complications.
The Federal Drug Administration (FDA) is not recommending that the Sprint Fidelis leads be removed, as they do function properly in most cases. But it has said it might reexamine the stress tests it has been requiring on such defibrillator leads.
If you have one of these Medtronic defibrillators, or know someone who does, and would like more information about what you should do, please contact one of our experienced personal injury lawyers today.