After two patient deaths, Boston Scientific recalls pacemaker
Photo | Courtesy Boston Scientific
Boston Scientific headquarters in Marlborough
Boston Scientific, a Marlborough medical device manufacturer, has recalled a subset of its Accolade pacemakers due to battery issues leading to malfunctions, where two patient deaths have been reported.
The portion of pacemakers, including an approximately 13% subportion of the company’s Accolade, Proponent, Essentio, and Altrua devices, have an increased risk of entering safety mode, which provides back-up pacing under critical circumstances, according to the manufacturer's recall notice.
“Boston Scientific voluntarily issued a product advisory involving a subset of specific types of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) because of the potential for these devices to transition to safety mode due to an elevated internal battery impedance,” Boston Scientific said in a Wednesday email to WBJ.
The devices’ safety modes are not meant to replace chronic pacing therapy as the setting may not provide the needed functions for a patient's cardiac conditions.
“This behavior can occur later in device life and may require early replacement for some patients. No devices within the advisory population remain available for implant and the most common clinical impact has been early device replacement,” said Boston Scientific.
The two reported deaths of pacemaker-dependent patients had their devices enter safety mode in a medical setting, according to the notice.
There are no devices within the advisory population available for use, as those pacemakers were built before September 2018.
The U.S. Food and Drug Administration issued a safety communication statement Monday, saying although the recall applies to a subset of the company’s Accolade pacemakers, the FDA is conducting an ongoing evaluation in collaboration with Boston Scientific to assess the potential risk of the issue across all Accolade pacemakers and identify further mitigation measures as necessary.
“Physicians following patients with devices included in the advisory population have been given recommendations intended to mitigate the risk of the behavior and will reach out to patients directly if a separate appointment should be made to assess their device,” said Boston Scientific.
Mica Kanner-Mascolo is a staff writer at Worcester Business Journal, who primarily covers the healthcare and diversity, equity, and inclusion industries.
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