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Items: 10

1.

Inadequate Device Operator Training

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

MedGen UID:
412231
Concept ID:
C2346480
Finding
2.

Inadequate User Interface

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

MedGen UID:
361527
Concept ID:
C1881162
Finding
3.

False Positive Result

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

MedGen UID:
361422
Concept ID:
C1880724
Finding
4.

Unable to Obtain Satisfactory Coronary Sinus Access

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

MedGen UID:
473903
Concept ID:
C3272270
Finding
5.

Unable to Obtain Satisfactory Vascular Access

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

MedGen UID:
473904
Concept ID:
C3272271
Finding
6.

Unable to Obtain Acceptable Pacing Thresholds

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

MedGen UID:
473902
Concept ID:
C3272269
Finding
7.

Failure to Adequately Clean

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]

MedGen UID:
1627733
Concept ID:
C4524795
Finding
8.

False Negative Result

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]

MedGen UID:
361421
Concept ID:
C1880722
Finding
9.

Device in back-up Mode

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]

MedGen UID:
1833497
Concept ID:
C5785719
Finding
10.

Unable to Position Lead In tributary Vein of Coronary Sinus

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]

MedGen UID:
473906
Concept ID:
C3272273
Finding
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