Voluntary Recall Issued for Medtronic Pacemakers and Implantable Defibrillators
Medtronic, a leading manufacturer of medical devices, has voluntarily recalled several pacemaker and implantable defibrillator models due to serious defects. While the FDA did not request Medtronic’s actions, they were classified as Class I recalls, which is the FDA’s most serious classification. A recalled item is categorized as such if there is a reasonable probability that its defect will cause serious, adverse health consequences or death.
Medtronic pacemakers and implantable defibrillators are life-saving devices designed for people suffering from heart rhythm/rate abnormalities. Cardiac patients with these devices trust that they will safely provide appropriate treatment in an effective manner. A pacemaker or implantable defibrillator defect can lead to serious health complications. In the most serious of cases, the heart is unable to circulate blood throughout the body, causing death.
Medtronic Pacemaker Recalls
In November 2005, Medtronic voluntarily recalled certain Sigma Series pacemakers because of a faulty wire connecting the device’s main circuitry and its header. The wiring defect could potentially lead the device to improperly monitor a patient’s heart rate or could cause the pacemaker to cease working. A patient would have no way of knowing that the wire was defective.
As of July 31, 2007, approximately 20,700 patients were still implanted with a Medtronic pacemaker manufactured with the defective wires. Thus far, there have been 102 documented cases of device failure. Currently, there is no test available to determine if a Medtronic pacemaker is defective. Patients implanted with a Medtronic pacemaker are advised to consult with their physician about replacing the device.
Medtronic Implantable Defibrillator Recalls
On October 15, 2007, Medtronic issued a voluntary recall of their implantable defibrillators due to defective Sprint Fidelis leads. The model numbers of the recalled defibrillators with these defective leads are 6930, 6931, 6948 and 6949. The recalled models were manufactured between September 2004 and October 2007.
The Sprint Fidelis leads are wires that connect the defibrillator directly to the heart. Defective Sprint Fidelis leads can fracture, preventing the defibrillator from delivering lifesaving treatment or prompting it to deliver painful, unnecessary shocks. Currently, there is no test available to determine if leads will fracture in the future.
Medtronic first issued a warning to physicians about the defective defibrillator leads in March 2007, but continued to manufacture the product until the October recall. As of October 4, 2007, five deaths and several cases of major complications have been documented in which a fractured Sprint Fidelis lead may have been a contributing factor.
Medtronic Liability and Legal Recourse
Medtronic’s inability or unwillingness to properly inform doctors and patients about the design defects in their pacemakers and implantable defibrillators renders the medical device manufacturer liable for any associated injuries or death.
If you believe that you or someone you know may have suffered health complications due to a faulty Medtronic device, you should be aware of your legal rights. The lawyers of Levin, Simes, Kaiser & Gornick have extensive experience protecting the rights of personal injury victims. Contact their offices at (800) 901- 4001 to learn more about how to protect yourself and find out if you are eligible for compensation.
Levin Simes Kaiser & Gornick, LLP
44 Montgomery Street, 36th floor
San Francisco, CA 94104
Ph: 1.800.901.4001
Fax: 415.981.1270
