ATTENTION FDA RECALL!!
GUIDANT / MEDTRONIC
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
An Implantable Cardioverter Defibrillator ( ICD ) is a device that is implanted in the chest to monitor for and, if necessary, correct episodes of abnormal heart rhythm ( ARRYTHMIA ). ICDs can generate (1) a series of precisely timed low-intensity electrical pulses to reset the heart to normal rhythm when the heartbeat becomes faster than normal ( VENTRICULAR TACHYCARDIA ), and (2) electric shocks that may feel like a sudden kick in the chest to stop potentially fatal quivering of the heart ( VENTRICULAR FIBRILLATION ). In addition, the ICD may be programmed to work as a pacemaker and send small electrical signals to pace the heart whenever it detects an abnormally low heartbeat ( BRADYCARDIA ).
ICDs are among the fastest-growing group of medical devices; in the year 2005 alone, more than 200,000 patients are expected to have one implanted. An ICD can cost up to $25,000 for the device itself and uncomplicated hospital and doctor costs can run another $15,000 to $25,000.
GUIDANT FAILED TO WARN DOCTORS AND PATIENTS AND DID NOT DISCLOSE KNOWN FLAWS IN ITS ICDs FOR THREE YEARS
Guidant came under fire in the spring of 2005 after The New York Times reported that it failed to alert physicians and heart patients about a potential problem with the VENTAK PRIZM DR model defibrillator. Since then, Guidant has admitted to knowing of malfunctions in its ICDs for three years now but continued to sell the defective ICDs and allowed them to be surgically implanted in patients - knowing patients were at risk for severe failures that obviously could lead to severe complications including death.
FDA RECALLS 50,000 DEFECTIVE ICDs MANUFACTURED BY GUIDANT
On June 17, 2005 , the FDA issued a nationwide RECALL of Guidant ICDs because the devices may develop an " internal short circuit without warning ", resulting in failure to deliver a shock when needed. In addition, Guidant recently informed the FDA that certain ICDs are subject to " memory errors which may affect device performance ."
THE FDA HAS CLASSIFIED THE RECALL OF 20,000 OF THE DEVICES AS "CLASS 1" ( THE MOST URGENT TYPE OF RECALLS ) BECAUSE THE DEFECTS " COULD CAUSE SERIOUS INJURY OR DEATH ."
Please click here for a complete list of the devices covered by the recall
FDA WARNING
The FDA has advised patients to take the following steps:
- Contact your doctor to determine if you have an affected ICD
- Contact your doctor if you feel an electrical shock from your device
- Contact your doctor or go to the nearest emergency room if you hear an audible "beeping" from your ICD.
Click here to receive more information and a free Guidant ICD case evaluation
FDA RECALLS DEFECTIVE MEDTRONIC ICDs
On February 11, 2005 the FDA announced that Medtronic was recalling certain ICDs due to a battery shorting defect which results in rapid battery depletion leading to loss of device function. Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action.
On June 21, 2005, the FDA criticized Medtronic's procedures for following up on complaints about an external defibrillator, including a failure to properly investigate a patient's death.
The letter focused on damaged cable connectors in the devices, which are designed to deliver a powerful shock to patients experiencing sudden cardiac arrest. The damaged cables can cause the wrong amount of power to be delivered. The problems highlighted in the document "may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems," the letter said.
Please click here for a complete list of the devices covered by the recall
Click here to receive more information and a free Medtronic ICD case evaluation
