Medtronic (NYSE:MDT) has released an urgent field safety notice warning of issues with a subset of its model 53401 single chamber external pacemakers in which the device may experience an unexpected power on reset.
The Fridley, Minn.-based company said that the issue is due to an initial version of the firmware for the device which allowed for an unused, unterminated digital input/output pin to act as an input. The unterminated pin was found to act as an antenna to detect external electrical signals, despite the device expecting it to be silent, according to the notice.
Upon detecting an electrical signal, the firmware may lock up and cause a power on reset, which will cause the device to stop functioning for approximately seven seconds while it reboots, according to the field safety notice.
Medtronic said that it has received 17 reports of the issue, with no patient deaths or complications related to it so far. Affected devices include model 53401 EPGs with serial numbers lower than MDB05000 distributed between February 2017 and November 2017, according to the notice.
The company said it has received approval for a firmware correction that should correct the issue, and advised customers with affected devices to send them back to Medtronic to receive the update.
Earlier this month, the FDA labeled a Medtronic voluntary select recall of its HeartWare HVAD systems over issues with unexpected power source switching as Class I.
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