The Food and Drug Administration (FDA) recently warned that some implantable defibrillators manufactured by St. Jude Medical may be defective.
These implantable devices are used to provide pacing for patients with slow heart rhythms, and electrical shock or pacing the hearts of patients with extremely fast heart rhythms, according to the FDA. Both devices are implanted in the chest with wires that go into the heart, according to Contemporary Clinic.Both devices have experienced issues with the lithium-based batteries that provide their power. The FDA and St. Jude Medical are now warning that battery replacement indicator alerts must be addressed immediately.
The battery alert typically allows a three-month lead time for battery replacement, but some batteries have lost power in as little as 24 hours from the time the patient received the the alert. A chemical reaction that causes deposits of lithium can cause a short circuit in the device that is responsible for the rapid battery failure.
Full battery drainage can occur within one day to a few weeks after the alert is received, according to the FDA. If the battery drains quickly, the device will not be able to perform the necessary pacing or shocks, and this could lead to the patient’s death.
According to the FDA, 398,740 defective devices have been sold worldwide, but only 841 defibrillators have been returned because of premature battery drainage thus far. Thus far, two deaths have been associated with a device not delivering the necessary shock due to battery drainage. An additional 10 patients have fainted because the device did not providing pacing therapy, the FDA reported. Thirty-seven patients report they experienced dizziness from lack of pacing. The FDA said more patients may have been affected because it is likely that not all instances of battery depletion were reported.
St. Jude Medical recommends that patients program their device to deliver vibratory elective replacement indicator alerts, and use the St. Jude Medical home monitoring system to monitor battery status. Some patients, however, may not detect the alert before battery depletion, and monitoring may not be sufficient for patients who are dependent on the devices for pacing, according to the FDA. The FDA recommends that doctors consider determine whether their patient’s device should be replaced.
If a pacemaker-dependent patient has a device that has reached elective replacement indicator status, the FDA said this should be treated as a medical emergency, and the device should be replaced immediately.
The FDA will continue to monitor the affected devices for additional adverse events or deaths associated with battery depletion, according to Contemporary Clinic.