Failure to Spike Medical Device Problem

Failure of device to generate a correctly-shaped pacing output, for example, a waveform that is too wide. (Food and Drug Administration)

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Failure to Shock with Inadequate Defibrillator Threshold Safety Margin

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

Failure to Shock or Properly Shock Medical Device Problem

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

Failure to Separate Medical Device Problem

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

Failure to Sense Medical Device Problem

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

Failure to Pace or Properly Pace Medical Device Problem

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

Failure to Osseointegrate Associated with Medical Device

Issue associated with the failure to see direct anchorage of an implant by the formation of bony tissue around the implant without…