Any patient with a Medtronic cardiac resynchronization therapy pacemaker (CRT-P) is at risk of device failure that causes rapid battery depletion. If the pacemaker is drained of its battery life, the device will no longer deliver therapy to the heart.
So far, there have been three patient reports that resulted in a loss of pacemaker function, resulting in one death.
Pacemakers operate as if the body functioned on battery life. They are designed to provide “pacing” for patients with a slow heart rhythm (bradycardia) or heart failure. Pacemakers are implanted under the skin in the upper chest with insulated wires connected to the heart allow the heart to function at a normal rate through an electric current. One of the most important components is the capacitor, which stores the electric energy.
Pacemakers are designed to last anywhere from 7.5 and 15 years, or 6 to 10 years before the battery needs replacement. Most pacemakers use Lithium Ion batteries. When the pacemaker works correctly, both patients and health care providers are able to communicate with the device to check on battery levels or general functionality through the Medtronic MyCareLink Monitor.
Additionally, providers receive notifications through Medtronic’s CareAlert, either wirelessly through a connection to the pacemaker or manually. The patient must have the device programmed to the “ON” position in order for this to happen. Most importantly, the patient and health care provider will be notified if the battery levels drop through an Elective Replacement Indicator (ERI).
According to a Food and Drug Administration announcement issued on May 7, 2019, there have been three patients who suffered from an unfortunate defect and lost battery life within nine months of implantation; one of which, resulted in death.
One patient experienced a sense of dizziness at their follow-up appointment. Their doctor was unable to communicate with the device and the patient had to get a replacement. The third patient had not yet received the pacemaker implant because the health care provider
According to an announcement on the Medtronic website, there have been roughly 266,000 devices distributed worldwide since February 2017.
Having a pacemaker implanted already puts you in a precarious situation. To top it off, patients should feel confident the device that keeps their heart functioning is working with 100% efficiency, there is no room for error.
Capacitor Crack Leading to Rapid Battery Depletion
The FDA has identified the problem is with a crack in the device’s capacitor. When this happens, it can create an electric short and drain the battery life much sooner. As with any battery, once it’s drained it will stop working and the pacemaker will not deliver therapy to the heart. Those that are pacemaker dependent are at the highest risk for a serious, if not fatal, outcome.
Patients are advised to use their remote monitors to check on levels, but only for the Azure, Percepta, Serena, and Solara devices. Those with the Astra device do not have wireless capability. For a full list of affected devices, please scroll down.
The pacemaker or CRT-P device should be immediately replaced in the event of an ERI alert. Unfortunately for many patients, there is no way to identify premature battery depletion or to accurately predict remaining battery life, should the ERI warning appear.
The FDA advises patients to immediately seek medical care if you feel lightheaded, dizzy, experience chest pain, severe shortness of breath, or if someone you are caring for has lost consciousness.
Devices at risk of a capacitor crack:
- Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01
- Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01
- Percepta models: W1TR01, W1TR04, W4TR01, W4TR04
- Serena models: W1TR02, W1TR05, W4TR02, W4TR05
- Solara models: W1TR03, W1TR06, W4TR03, W4TR06