Boston Scientific recalls a decade's worth of Ingenio pacemakers over risk of unexpected system resets

Approximately 48,000 pacemakers distributed between November 2011 and August 2020 have been recalled by Boston Scientific this summer, after the company became aware of a battery issue that could cause the devices to send electrical impulses to the heart at an incorrect or irregular rate.

The devicemaker launched the recall at the beginning of June, and this month the FDA gave it a Class I rating, indicating a serious risk of injury or death associated with use of the affected devices.

The issue in question stems from a flaw in the Extended Life batteries found in Boston Scientific’s Ingenio family of dual-chamber pacemakers and cardiac resynchronization therapy pacemakers, or CRT-Ps.

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After several years of use—but up to several years before their service life has run out—the batteries have been found to reach a high level of internal impedance. Once that happens, a sharp decrease in battery voltage can occur during the high-power consumption process of transmitting data from the pacemaker via telemetry, incorrectly triggering a system reset. If the system resets three times within 48 hours, it’s sent into safety mode.

Though the pacemakers will continue to work in safety mode, users may experience a loss of pacing as the systems aren’t correctly calibrated to their individual heart rhythms. Once in safety mode, the devices can’t be reprogrammed; the issue can only be remedied with a total replacement of the pacemaker.

The potentially defective devices, which were manufactured only through December 2018, are no longer available for implant.

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If left untreated, per the FDA, loss of pacing by the devices can result in a worsening of heart failure or even death. So far, 65 incidents linked to the faulty batteries have been reported to the agency, including three cases in which the users had to temporarily receive external pacing delivered by their healthcare providers.

However, in a June 3 notice sent to affected providers and patients, Boston Scientific estimated that one-third or more of the affected Ingenio devices—totaling at least 16,000 pacemakers—could mistakenly be sent into safety mode before the allotted time for battery replacement.

Despite that high risk, the company is recommending that the devices be replaced only once they incorrectly enter safety mode (at which time an alert will be sent to the user’s care team), and not preventively. Instead, for the most part, patients implanted with the pacemakers should stick to their originally prescribed follow-up appointment schedule until the last year of the battery’s expected service life, at which time follow-ups should take place every three months until replacement.

Still, preventive replacements can be considered on a case-by-case basis based on factors like underlying health issues and pacemaker dependence, according to Boston Scientific. In those cases, replacement should be scheduled only once the expected remaining service life of the battery is within four years for the dual-chamber pacemakers and three years for the CRT-Ps.