The British Medicines and Healthcare Products Regulatory Agency (MHRA) issued a medical device alert over the Medtronic EnTrust Defibrillator because of battery malfunctions. Subsequently, the U.S. Food and Drug Administration (FDA) announced that Medtronic recalled the device.
What Is the Medtronic EnTrust Defibrillator?
The Medtronic EnTrust Defibrillator is an “implantable cardioverter defibrillator” (ICD) that delivers controlled electric shocks to the heart muscle in patients whose hearts do not beat properly. The ICD contains a battery to deliver the shocks, and insulated leads connect the ICD to the heart muscle to both monitor the heart rate and deliver sufficient voltage to keep it beating regularly. The difference between an ICD and a pacemaker is that the latter are meant to be temporary remedies for slow heartbeats while ICDs are permanent and protect against irregular heartbeats.
Between 2005 and 2012, Medtronic sold 69,000 EnTrust Defibrillators worldwide, but about 39,000 were active inside of patients in 2012.
The Medtronic EnTrust Defibrillator Might Cause Life-Threatening Side Effects
On March 16, 2012, the MHRA issued a medical device alert for the EnTrust Defibrillator because the battery could deplete after only two-and-a-half years. If the battery runs out, the device will not deliver the shocks necessary to keep a recipient alive. As a result, recipients might suffer severe or fatal side effects. Medtronic calculates that the failure rate for EnTrust ICDs is 0.15 percent at most, but it could be higher.
On March 22, 2012, the FDA classified an “Urgent Medical Device Correction Letter” Medtronic sent to physicians on March 6, 2012, as a Class II recall. This means the device might cause temporary health problems.
RLG’s EnTrust Defibrillator Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an EnTrust Defibrillator lawsuit on your behalf if necessary. RLG will also keep you up to date on any EnTrust Defibrillator class action lawsuits, FDA EnTrust Defibrillator warnings, and additional EnTrust Defibrillator FDA recall announcements. If you or a loved one received an EnTrust Defibrillator and believe it caused an injury, contact RLG today.