Medtronic (NYSE:MDT) is suspending distribution and selectively recalling approximately 156,957 of its Adapta, Versa and Sensia dual-chamber pacers over circuit error issues that could affect overall device functionality, according to an urgent release from the company.
The issue occurs when the devices are programmed to a dual chamber mode with atrial-sensing, the Fridley, Minn.-based company said, and can leave the device unable to provide pacing until a ventricular-sensed event is detecting.
“Once a VS is detected, normal pacing functionality is restored immediately. If a VS is not detected, the device will withhold both atrial and ventricular pacing,” Medtronic said in its release. Until a VS is detected, the company added, the device will also be unable to initiate a session with a device programmer, a CareLink remote monitor, and will not respond to a magnet.
The company said that it has received four reported occurrences of the error which occurred in two patients, both of whom experienced a pause in pacing therapy that “was clinically apparent due to this circuit error.”
“These reported events occurred in three (3) devices from a total of 156,957 devices sold worldwide. No deaths have been reported as a result of this issue,” Medtronic said in its release.
The company said it estimates that a device in a susceptible pacing mode has a 2.8% chance per month of experiencing a pacing pause of 1.5 seconds or longer.
“Risk is minimized in patients who have an escape rhythm adequate to prevent syncope during a loss of ventricular pacing, since a VS restores full device functionality. No risk of a pause due to this circuit error exists for patients programmed to a non-susceptible pacing mode,” Medtronic said.
The cause of the issue is related to a design change to an integrated circuit in a small group of devices distributed between March 10, 2017 and January 7, 2019, the company said.
Medtronic clarified that single chamber and dual chamber pacing modes that do not sense atrial activity were not susceptible to the error.
The company said that the modes susceptible to the circuit error include DDD, DDR, DDI, DDIR, VDD, ADI, ADIR, VDI, VDIR, ODO, OAO and MVP, but only when operating in DDD, DDR, DDI or DDIR mode.
Medtronic said that the modes not susceptible to the error include VVI, VVIR, DVI, DVIR, AAI, AAIR, VOO, VOOR, AOO, AOOR, DOO, DOOR, OVO, VVT and AAT.
Medtronic added that it is currently developing a software update to correct the issue, and that it hopes to have submitted the update to regulatory bodies during the second half of this year. The company added that it will notify its customers with updates as they become available.
The company provided a list of patient management recommendations to limit the vulnerability of patients with affected devices from experiencing the error. The company recommended programming devices “to a non-susceptible pacing mode as the primary mitigation for patients implanted with an affected device until the software update has been installed.”
For patients unable to change to a non-affected mode, Medtronic recommended either clinical monitoring for the issue or possible device replacement.
“The estimated per patient mortality risk due to this issue is 0.021% when programmed to a susceptible pacing mode over the estimated time until the software update becomes available. This risk is comparable to the Medtronic estimated per-patient mortality risk associated with a device replacement (0.027%),” Medtronic said in its release.
The company also advised any patients in a susceptible mode to seek immediate attention if they experience new or unexpected systems consistent with pacing issues. Other than the shift to a non-susceptible mode, Medtronic said that “no additional programming options have been identified to mitigate the issue.”
Last week, Medtronic said that it launched its MyCareLink Heart mobile application intended to connect users’ smartphone devices directly to the company’s portfolio of connected pacemakers, touting it as the first such mobile application of its kind.
