A Dead Canary in the Mine or a Bizarre Aberration in a Leadless Pacemaker?

Device recalls and malfunctions are feared by manufacturers, patients, and physicians alike. Initial reports of malfunctions typically include a small number of patients but may be followed by an increasing incidence of these failures. In October 2016, the manufacturer halted implantation of Nanostim, a cardiac leadless permanent pacemaker, because 7 of 1423 devices experienced early battery depletion. Very little other data have emerged on the real incidence of early battery failure. Investigators at a single German center have now reported on their experience with 14 Nanostim implants.

Six implants experienced early battery depletion. The median time from implantation to battery failure was 38 months (range, 30–45 months). The median time …