Medtronic has issued an “Urgent Medical Device Recall” voluntarily recalling and suspending distribution of a subset of Medtronic dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta; Versa; and Sensia. The affected medical devices, when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality.
For this error to occur, a unique combination of events must take place while the device is processing an atrial-sensed event. If this error occurs, the device will be unable to provide pacing until a ventricular-sensed event (VS) is detected. 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. In addition, until a VS is detected, the device will be unable to initiate a session with a programmer, initiate a session with a CareLink remote monitor, or respond to a magnet.
In announcing the recall, Medtronic stated that through January 4, 2019 it was aware of four reported occurrences in two patients where a pause in pacing therapy was clinically apparent due to this circuit error. These reported events occurred in three devices from a total of 156,957 devices sold worldwide. No deaths have been reported as a result of this issue.
Medtronic identified the root cause for this issue to be related to a design change to an integrated circuit in a subset of devices that were distributed between March 10, 2017 and January 7, 2019. Medtronic stated that it is developing a software update that can be installed into affected devices to correct this issue, with submission of this software update to regulatory agencies by the 2nd half of 2019. Medtronic recommends programming to a non-susceptible pacing mode as the primary mitigation for patients implanted with an affected device until the software update has been installed.
Medtronic estimates that on average, 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 stated, “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%).”
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