Fair

Extremely weak; threatened with syncope.

Issue associated with problems removing the materials used to construct the cover or outer wrapping of the device.

A clinical finding indicating less than normal growth in an infant or child, or a state of global decline in an…

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.