En español | Thousands of pacemakers sold by Abbott over nearly four years were recalled because of the risk of electrical shorts that can result from moisture getting inside the devices, according to an announcement from the Food and Drug Administration (FDA).
The 61,973 Scalable Bradycardia Platform (SBP) pacemakers were sold under the Assurity and Endurity model names between April 29, 2015, and Feb. 20, 2019. The implantable pacemakers detect when the heart is beating too slowly and send a signal to the heart to make it beat at the correct pace. The pacemaker manufacturer was formerly known as St. Jude Medical before merging with Abbott in January 2017.
The electrical shorts that triggered the recall may cause the devices to stop pacing the heart, report inaccurate information to doctors or drain the battery faster than expected. The shorts could also lessen the time between the pacemaker's initial elective replacement indicator (ERI) warning and the subsequent end-of-service (EOS) warning. These indicators alert doctors when a pacemaker needs to be replaced.
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The FDA, which has received 135 reports of injuries, identified the recall as a Class I, its most serious type, because of the risk of serious injury or death. If the device is unable to effectively pace the heart, the wearer may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness or discomfort. Shorter battery life can result in the user's needing to replace the pacemaker sooner than expected. What's more, needed treatment may not be provided if the device does not relay accurate information. Pacemakers record and transmit readings wirelessly to doctors in a process known as telemetry.
Signs of Pacemaker Malfunction
- Slow or irregular heartbeat
- Shortness of breath
Abbott blamed the defect that allowed moisture to get inside some devices on incomplete mixing of an epoxy during manufacturing. None of the affected devices is still available to be implanted.
Recommendations to patients, physicians
Abbott does not recommend precautionary replacement due to “the very low rate of occurrence and the low potential for patient harm when prompt replacement is performed following an unexpected alert.” The company cited a malfunction rate of 0.049 percent.
In a safety notice Abbott sent on March 15 to inform doctors of the issue, the company made these recommendations for patients with the affected pacemakers:
- Routine follow-ups should continue following standards of care and clinical protocol. Ensure a review of device functions such as battery voltage or any change in battery consumption. Additionally, evaluate the potential risks if the patient is dependent on the pacemaker and unable to be reliably tracked via remote monitoring.
- Promptly replace devices that unexpectedly signal ERI or EOS warnings.
- Patients should be tracked using Abbott's Merlin.net patient monitoring system to benefit from alert monitoring between routine device checks. ERI and EOS alerts are currently monitored daily.
Those with questions should contact Abbott Technical Support at 800-722-3774. Health care professionals and consumers may report adverse reactions or problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Aaron Kassraie joined aarp.org as a staff writer and associate editor of veterans content in 2019. He previously covered U.S. foreign policy as a correspondent for Kuwait News Agency's Washington bureau and worked in news gathering for USA Today and Al Jazeera English.