Failure to Thrive

Failure of device to generate a correctly-shaped pacing output, for example, a waveform that is too wide.

The cardiac lead failed to administer a shock and had an inadequate defibrillator threshold safety margin.

Issue associated with the inability of device and/or device components to provide an appropriate or successful electrical shock.

Issue associated with the device or one of its components failing to detach or separate as intended.

Issue associated with the failure of a device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a…

Issue associated with the inability of device and/or device components to generate a therapeutic simulated heart beat via electrical impulses once arrhythmia…