FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths
The U.S. Food and Drug Administration (FDA) and Boston Scientific today sent an urgent alert to patients and healthcare providers about the potential need for early device replacement of some Accolade pacemakers.
The company announced a recall for a subset of its Accolade devices because of an increased risk of permanently entering the safety mode. This has limited functionality, making the device unable to properly regulate the heart’s rhythm and rate. Most of the activations have occurred during follow-up office or hospital visits when the devices are interrogated for data.
There have been two reported patient deaths in pacemaker dependent patients after the devices went into safety mode in an ambulatory outpatient medical setting. Boston Scientific said about 70% of safety mode events occurred during in-office interrogations from a Latitude programmer, and the remaining incidents took place in an ambulatory setting.
"The risk of harm may be greater when safety mode occurs in an ambulatory setting, as patients are not in a monitored clinical environment," the company said in its recall notice.
The recall includes a subset of the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy (CRT) pacemakers. The number of impacted devices is about 203,000, while the tally of confirmed malfunctions is 697, Boston Scientific said in its recall notice.
The FDA is warning that any of these devices that enters safety mode needs to be replaced quickly if a patient is dependent on the pacemaker.
Boston Scientific said the issue is due to the battery under-powering the system because of a manufacturing problem. The recall identified the issue and the company is working with the FDA to evaluate the potential risk across all Accolade pacemaker devices and identify additional mitigation strategies.
Cause of the pacemaker malfunction
Boston Scientific in its urgent letter to providers said the subset is approximately 13% of devices from the Accolade family. The company said there was an unanticipated concentration of lithium salts resulting from variability of battery assembly techniques between workers. The higher amount of salts causes latent high battery impedance, which can initiate safety mode during telemetry or other normal, higher-power operations
The company said the subset of devices impacted by the recall were built before September 2018, so here are no remaining devices available for implantation. The issue only impacts devices that were already implanted in patients.
The FDA said the manufacturer plans to implement updated manufacturing work instructions for the process used to make the cathodes for Accolade product batteries. In addition, the manufacturer is developing a software update to detect battery health in all Accolade pacemaker devices.
Recommendations for patients and providers on next steps
The FDA said patients should work with their healthcare provider to monitor their Accolade pacemaker devices, either remotely or during their next scheduled in-office follow-up visit. Providers should discuss if patients with these devices are candidates for remote monitoring to enable regular updates to be sent to the physician's office, including any safety mode activation alerts.
If monitoring indicates that a device has entered safety mode, healthcare providers need to quickly schedule surgery to replace the pacemaker. Patients should contact their provider if they have new or worsening symptoms, such as lightheadedness or loss of consciousness.
The FDA said providers should review the recall notice, which includes the following important information:
• Description of the battery problem and clinical impact of safety mode.
• Recommended actions for individual patient evaluation, device replacement and follow-up intervals.
• Model numbers and unique device identifier (UDI) information.
The FDA encouraged monitoring patients for changes in symptoms or remote monitoring to watch for safe mode activation, but general prophylactic device replacement is not being recommended. Safety mode can only be identified through office visits or through remote monitoring using the Boston Scientific Latitude Communicator system, the FDA said.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com