Defective Pacemaker Has Caused Death, FDA Warns
Some St. Jude Medical pacemakers have been failing in patients as early as 24 hours after a low battery alert.
The FDA has recently warned that some implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators manufactured by St. Jude Medical may be defective.
These devices are used to provide pacing for patients with slow heart rhythms, and electrical shock or pacing for patients with extremely fast heart rhythms, according to the FDA. Both devices are implanted into the chest with wires that go into the heart.
Both devices have been experiencing issues with the lithium-based batteries that provide power. The FDA and St. Jude Medical are now warning that elective replacement indicator alerts must be addressed immediately.
The alerts typically have a normal lead time for replacement of 3 months, but some have lost power within a 24-hour period of time. This issue is being caused by deposits of lithium that cause rapid battery failure.
Full battery drainage can occur within 1 day to a few weeks after the alert is received, according to the FDA. If the battery drains quickly, the devices will not be able to perform pacing or shocks, and could lead to patient death.
There have been 398,740 defective devices sold worldwide, and only 841 have been returned due to premature battery drainage thus far. There have been 2 deaths associated with the devices not performing shock therapy due to battery drainage.
Another 10 patients have fainted from the devices not providing pacing therapy because of battery depletion, the FDA reported. Dizziness from lack of pacing was experienced by 37 patients. Since battery depletion may not be reported, there may be more patients affected.
It is recommended that patients program their device to deliver a vibratory elective replacement indicator alerts, and use the St. Jude Medical’s home monitoring system to monitor battery status. Since there is a low failure rate and significant risks associated with surgical replacement, monitoring is recommended for most.
However, some patients may not detect the alert before battery depletion, and monitoring may not be sufficient for patients who are dependent on the devices for pacing with an untolerated or absent intrinsic heart rate, according to the FDA.
It is recommended that healthcare providers determine whether their patient’s device should be replaced.
Pacemaker-dependent patients with a device that has reached elective replacement indicator status should be treated as a medical emergency, and the devices should be replaced immediately.
The FDA will continue to monitor the affected devices for additional adverse events or deaths associated with battery depletion.
