[ad_1]
For some end-stage heart failure patients, the Medtronic HeartWare Ventricular Assist Device (HVAD) System helps the heart by supporting the weak left ventricle and providing additional blood flow. On Thursday, the U.S Food and Drug Administration (FDA) issued an alert warning these patients that Medtronic is recalling batteries used to operate the system because the batteries may experience electrical faults that cause them to unexpectedly fail.
The federal health agency has labeled this a “Class 1 recall,” which is the most serious kind of recall. Loss of power from these batteries (model number 1650DE) can cause serious health consequences or even death.
Medtronic has already reported 1,159 complaints, six injuries, and one death related to this issue.
If the battery has an electrical fault, the controller may not receive power, or the battery charger may be unable to accept a charge or possibly appear to remain charged when in use. If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working.
The device, which is implanted in the chest, is for end-stage heart failure patients who are waiting for a transplant and for those who are not eligible or are too sick to receive a heart transplant, and whose symptoms cannot be managed by medications. The latter use is known as “destination therapy,” which can extend a patient’s life and improve their quality of life.
The HVAD System features a pump implanted in the space around the heart (pericardium), a controller that controls the speed and function of the pump, a tube inserted into the heart to drain the blood, and a tube inserted in the aorta for the blood that is being pumped. The controller is powered either by batteries or a power supply that can be connected to a standard electrical power outlet.
In June 3, 2021, Medtronic stopped the distribution and sale of the HVAD System due to safety concerns. At that point, the medtech giant notified physicians to cease new implants of the HVAD System and transition to an alternative commercially available left ventricular assist devices (LVAD) for all future implants.
For patients who currently have the device implanted in their body, Medtronic does not recommend replacement of the system because — in the vast majority of cases — the risks associated with additional surgery outweigh the benefit of a replacement device.
Medtronic, however, continues to serve the needs of about 4,000 patients around the world who are currently implanted with the device.
To help avoid problems due to the faulty battery issue, the company has issued an urgent letter to users telling them to keep two sources of power connected to their controller and have fully charged spare batteries available at all times. The notice also encourages patients to be vigilant if the battery indicator lights do not decrease over time while the battery is in use, and to pay attention to the battery indicator lights. “Do not use a battery if the indicator lights do not light up,” warns Medtronic.
Patients with questions about this recall should contact Medtronic Patient Services at 800-635-3930 (Monday to Friday, 8 a.m. to 5 p.m. CT).
[ad_2]
Source link