Medtronic pacemaker alert notices can be chilling news to patients who use them. Since pacemakers are surgically implanted, the solution to these revelations may take days, weeks, or months to implement and in that time any number of complications. On May 7, 2019, the U.S. Food and Drug Administration (FDA) released a Medtronic pacemaker alert addressed to patients, caregivers, cardiologists, electrophysiologists, cardiac surgeons, and primary care physicians and described a potentially fatal complication with pacemaker power usage.
Summarizing The Medtronic Pacemaker Alert
The FDA Medtronic pacemaker alert was written to address cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected without warning patients or health care providers. As of May 7th, The FDA has been made aware of three device reports of a Medtronic implantable pacemaker or CRT-P battery fully draining because of a crack in the device’s capacitor. In the alert, the FDA mentioned that as of April 10, 2019, 131,889 devices have been sold in the U.S.
Medtronic pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) are surgically implanted cardiac assistance devices that help cardiac function in slow heart rhythms and heart failure. Patients may need a pacemaker or CRT-P if they have a condition like a slow heartbeat (bradycardia). Medtronic pacemakers are electronic and powered by lithium-ion batteries. One of the key electronic components is a capacitor, which stores electrical energy. This is the chief component that poses such risk according to the FDA Medtronic pacemaker alert.
The Medtronic pacemaker alert stated that if a capacitor in an implanted pacemaker or CRT-P is cracked, an electric short is generated which causes a battery to drain more quickly than expected. If a battery is ever totally drained, the device will no longer deliver pacing therapy. Patients who rely heavily on pacing or are pacemaker dependent are the most at risk for having potentially fatal outcomes.
Medtronic has also reported that with fully depleted batteries, healthcare providers cannot issue orders to change cardiac treatments, putting patients at greater risk for complications upon replacing the power source in the pacemakers. At this time there has been at least one confirmed death.
According to the FDA Medtronic pacemaker alert, capacitor cracking events occur within one year after the patient is implanted with the pacemaker or CRT-P, and on average the cracks begin within seven months of getting the device implanted. This is a worrying fact because these devices are designed to last between 7.5 and 15 years before requiring battery maintenance, depending on the device and the amount of usage.
Products affected by the Medtronic pacemaker alert included:
- Azure models
- Astra models
- Percepta models
- Serena models
- Solara models
In a turn of good news, Medtronic has received FDA approval for a new manufacturing process that has been developed to better detect capacitor failures and plans have been made for a different capacitor which reduces the risk of rapid battery depletion in newer pacemaker devices.
For more information about Medtronic devices and their risks. see Parker Waichman’s in-depth coverage of their products here.
Advice Given In The Medtronic Pacemaker Alert
In addition to giving an overview of the situation, the FDA Medtronic pacemaker alert included several points of advice for medical professionals and patients alike. Some of this advice includes information related to the Elective Replacement (ERI) Indicator function. Currently, patients and health care providers receive an Elective Replacement Indicator CareAlert notification when the battery level drops below a certain limit. With the new Medtronic pacemaker alert, the FDA advises healthcare providers to replace the pacemaker or CRT-P device immediately following an ERI alert. There is no testable to identify when defective Medtronic devices are approaching ERI, or to predict remaining battery life once an ERI notice is issued. It is, however, unlikely that the Medtronic has the 3 months remaining that the ERI is meant to signal.
The Medtronic pacemaker alert was so insistent that this notice be taken seriously that patients and caregivers were advised to treat pacemaker patients with a device that issues an ERI notification as a medical emergency.
The Medtronic pacemaker alert also calls for doctors to be aware of sudden battery level drops during follow up visits and remote transmissions. Decreases in battery level out of proportion to the life of the device from the time of implant may be a sign of impending malfunction even if the level remains within the normal range.
Pursuing Injury Claims Following The Medtronic Pacemaker Alert
Though this Medtronic pacemaker alert is a definite sign that the FDA and pacemaker manufacturers are taking the issue of cracked capacitors seriously, the the issue remains that many of the 131,889 Medtronic pacemaker patients have been affected by this issue. If you or a loved one have suffered cardiac issues or wrongful death due in part to a faulty Medtronic pacemaker, you will need excellent legal representation to gain the compensation you deserve. Parker Waichman LLP is that excellent representation.
At Parker Waichman LLP, teams of experienced trial attorneys are ready to take on your claims and get you the compensation you need to begin to return life to normal. Contact Parker Waichman today for your free consultation.