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. (Food and Drug Administration)

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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…

Failure to Meet Randomization Criteria

An indication that the subject has been unable to fulfill the criteria required for assignment into a randomized group.

Failure to Interrogate Medical Device Problem

Issue associated with the device failure to appropriately respond to signals from a system designed to interrogate its status.