These Medtronic Cardiac Defibrillator devices, used by patients who suffer from an irregular heartbeat, are surgically implanted under the collarbone and emit an electrical shock to jolt the heart back into regular rhythm.
To date, Medtronic has found this battery defect in several of its 87,000 devices. Thousands of patients throughout the world rely on these defibrillators, about 75% of Medtronic's defibrillators are implanted in U.S. patients and 13,000 have already had the device surgically removed. Currently, Medtronic is offering to replace the $20,000 device and pay several thousands of dollars in additional expenses but there are no definite plans to pay for the necessary second surgery.
The devices that have been affected include the following which were manufactured between April 2001 and December 2003:
In a similar situation, Medtronic recalled and replaced over 16,000 Implanted Defibrillators between 2001 and 2003 when it was discovered that a battery flaw might render the unit ineffective. In 2004, Medtronic announced a recall of their Micro Jewell II and GEM DR ICDs.
Medtronic, a key player in the worldwide medical technology race, distributes products and services to 5 million patients each year, generating $9 billion in annual sales.
Medical professionals advise that if you have a Medtronic defibrillator device implanted, talk to your doctor as soon as possible to find out more about your medical options.
If you have had the device replaced or plan to have it replaced, whether or not you suffered complications from the procedure, you may be entitled to compensation.
Medtronic Defibrillator ArticlesMedtronic: It's Not Just Sprint Fidelis
Sandy Wells never had an implantable cardiac defibrillator with defective Medtronic Sprint Fidelis leads in her body. That's the good news. The bad news is that she did have a Medtronic Synergy neurostimulator implanted under her arm in hopes of relieving her chronic migraine headaches.
Medtronic Shareholders Meeting: A Year of Lawsuits and Controversy
Medtronic Reducing Staff, Preparing for Defibrillator Lawsuits
More Trouble in Medtronic Heartland
Private Insurers Suing Medtronic
Device-Maker Medtronic Weighed Down With Lawsuits
Medtronic's Medical Device legal troubles far from Over
Medtronic Defibrillators In the NewsJUN-20-07: Medtronic announced that it is eliminating around 550 jobs from its Cardiac Rhythm Disease Management division because of a slow market for implantable cardioverter defibrillators. The defibrillators are implanted in the chest to shock hearts back into rhythm. [WKBT: MEDTRONIC]
MAY-31-07: Medtronic announced it will be laying off workers because of disappointing sales. The market for implantable defibrillators was hurt by a number of recalls of the devices. [PRESS: MEDTRONIC]
APR-20-07: A school district has filed a countersuit against Medtronic and two other companies claiming a Medtronic heart defibrillator did not work when a student's heart stopped during gym class. The student survived but suffered brain damage as a result of the incident. [RECORDNET: MEDTRONIC]
FEB-12-07: Number of heart patients suing Medtronic Inc. over faulty defibrillators has more than doubled in the past two months. [SEATTLE PI: DEFECTIVE MEDTRONIC DEFIBRILLATOR]
JUN-22-05: Medtronic fails to comply with FDA's requests to correct manufacturing problems and investigate complaints against the LifePak 12 external defibrillator. Approximately 60,000 LifePak 12 defibrillators are used in hospitals worldwide. The device is used to shock a failing heart but there have been reports of device failure. [WASHINGTON POST: DEFECTIVE DEFIBRILLATOR]
MAR-22-05: Health Canada safety information on Medtronic Implantable Cardiac Defibrillators, Marquis ICD and CRT-D. [HEALTH CANADA: MEDTRONIC DEFIBRILLATOR]
FEB-11-05: FDA announces Medtronic's warning about several of their implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). [FDA: DEFECTIVE DEFIBRILLATOR] FDA also announces recall of Medtronic's LIFEPAK 500 automated external defibrillators (AEDs). [FDA: MEDTRONIC DEFIBRILLATOR]