The US Food and Drug Administration has declared Medtronic’s recall of seven models of defibrillating cardiac rhythm devices, due to a risk for premature battery depletion, as Class I, which implies a potential risk for serious injury or death. A total of 444 complaints, but no deaths, have been reported in association with the 239,171 affected devices, the agency said in a statement today.
Physicians were notified of the company’s recall in early February. It covered implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) models Evera, Viva, Brava, Claria, Amplia, Compia, and Visia distributed from August 31, 2012 to May 9, 2018.
The devices could be subject to “an unexpected and rapid decrease in battery life” due to a possible short circuit that could lead to a device-replacement alert “earlier than expected.” Some devices may experience full battery depletion “within as little as one day” after such an alert.
Click here to continue reading: medscape.com
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. A person may need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.
Medtronic is recalling the specified ICDs and CRT-Ds due to an unexpected and rapid decrease in battery life. The decrease in battery life is caused by a short circuit and will cause some devices to produce a “Recommended Replacement Time” (first warning that the battery is low) earlier than expected. Some devices may progress from “Recommended Replacement Time” to full battery depletion within as little as one day.
If the user does not respond to the first warning, the device may stop functioning. The likelihood that this issue will occur is constant after approximately three years after device use.
There have been 444 complaints regarding these devices. There are 264 Medical Device Reports, with 18 injuries including people experiencing bradycardia (slow heart rhythm) or heart failure symptoms. Zero deaths have been reported.
Click here to continue reading: fda.gov