On February 10, 2005, Medtronic Inc. issued an alert to doctors about its family of Implantable Cardioverter Defibrillators (ICD) and CRT-D devices with batteries manufactured prior to December 2003. These pacemaker-like devices may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, battery depletion can take place within a few hours to a few days, after which there is a complete loss of device function. These automated devices, used by healthcare consumers 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:
- Marquis™ VR/DR
- Maximo™ VR/DR ICDs
- InSync I/II/III Marquis™
- InSync III Protect™ CRT-D
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. 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 risks and 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 in the News
- Medtronic Inc. notifies doctors that 28,000 of its Sigma pacemakers may have faulty wires. The company said the wires may separate from the circuit, in which the heart regulating device may fail, causing premature battery depletion, reduced heart rate response, failed pacing output, or loss of data transmission. The FDA may announce a recall for the Sigma pacemakers. (Nov-29-05) [ASSOCIATED PRESS]
- 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. (Jun-22-05) [WASHINGTON POST]
- Health Canada safety information on Medtronic Implantable Cardiac Defibrillators, Marquis ICD and CRT-D. (Mar-22-05) [HEALTH CANADA]
- FDA announces Medtronic's warning about several of their Implantable Cardioverter Defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). (Feb-11-05) [FDA]
- [MORE INFO ON GUIDANT DEFIBRILLATORS]
If you or a family member has a defective or recalled Medtronic defibrillator implanted, you may qualify for damages or remedies by making a claim or filing suit against the manufacturer. Please fill out the Medtronic case-evaluation form, or call Hollis Wright toll-free at 1-844-529-8255. Your case will be evaluated for free, and we will let you know whether you have a valid case against the manufacturer.
Click here to complete our free evaluation form, and submit your case to Hollis Wright for a free and confidential case-review and consultation.