M edtronic Sprint Fidelis Defibrillator Leads
On October 15, 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, used in many of its implantable defibrillators. According to Medtronic, this lead, a wire that connects the Medtronic defibrillator to the heart, could fracture or break inside a patient’s blood vessel, delivering a massive electrical shock. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. Five deaths have been linked to the malfunction.
This lead has been used in implantable Medtronic defibrillators since 2004, and most patients who received the devices since then have the potentially faulty leads. These leads are used only in the cardiac defibrillator device - the device that can deliver a shock to you when needed. It is not used with the pacemaker device.
Around 268,000 of these leads have been implanted in patients around the world, of these, over 172,000 have been implanted in patients in the United States. A company review of over 30 months of data showed a problem with the leads breaking. The company estimates that around 2%, or 4,000 to 5,000 people with this lead will experience a break within 30 months of having it implanted. If the lead fractures, it must be replaced, and this can be a difficult procedure.If the lead breaks, one of several things might occur. The implantable defibrillator will beep, alerting the patient to seek immediate medical attention. Or, the fracture can create a massive electrical shock that causes the patient extreme and sudden chest pain. In the worst case, the fracture of the lead can deplete the Medtronic defibrillator’s battery. If this happens, the Medtronic defibrillator can fail to deliver a necessary shock that is needed to save your life.
How do you know if you have one of these leads? Your implant card should identify all leads that are implanted in your body. The recalled leads have numbers that start with 6930, 6931, 6948 and 6949. The numbers may be difficult to read, and there may be a long series of numbers after these. If you have any questions, you should contact your Physician to determine a course of action. The manufacturer, Medtronic, is not advising that they be removed, unless a break is present, or problems result.
If you think you may have one of these implanted leads, or if you have had a problem with a lead, we would like to speak with you. Please fill out and submit our confidential questionnaire, or contact attorney William Bross by email at wlbross@hgdlawfirm.com, or phone Heninger Garrison Davis at 1-800-241-9779. Click here for our confidential questionnaire. |
