MedGen

Problem associated with facility not providing satisfactory initial and/or periodic user training covering operation of a medical device. [from NCI]

Problem associated with the means by which the operator and the equipment communicate or interact. [from NCI]

Problem associated with the device incorrectly reporting that something has been detected and may mislead the operator to take certain actions. [from NCI]

The coronary sinus / left ventricular lead was not implanted because the operator was unable to obtain satisfactory coronary sinus access. (ACC) [from NCI]

The coronary sinus / left ventricular lead was not implanted because the operator was unable to obtain satisfactory vascular access. (ACC) [from NCI]

The coronary sinus / left ventricular lead was not implanted because the operator was unable to obtain acceptable pacing thresholds. (ACC) [from NCI]

A device found in back-up mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device malfunction or due to operator error. [from NCI]

Problem associated with the device incorrectly reporting that something has not been detected and may mislead the operator into not taking certain actions when action should be taken. [from NCI]

Problem associated with the failure of the device or operator to remove any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of the device. [from NCI]

The coronary sinus / left ventricular lead was not implanted because the operator was unable to position the lead in the tributary vein of the coronary sinus. (ACC) [from NCI]