Pulse Generator, Permanent, Implantable

Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components:

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components:

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

Azure S DR MRI SureScan, Product number W3DR01

Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.

Merlin@home Transmitter REF EX1100

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

2090 Programmers with serial number prefixes PKK0 and PKK1:

Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.

ASSURITY Pulse Generator REF PM**** SN *********

Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

ENDURITY Pulse Generator REF PM**** SN *********

Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

Patient Connector, Model Number 24967

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.