CDE Detailed Report

Disease: Epilepsy
Sub-Domain: Devices
CRF: Implanted Devices Log

Displaying 1 - 21 of 21
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C18555 Device implanted comment text DevImpCommentTxt The free-text field to capture any comments related to an implanted device. The free-text field to capture any comments related to an implanted device. Comments Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Implanted Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C14506 Device implanted frequency DevImpFreq The electrical frequency (number of complete cycles of a periodic process occurring per unit time) as set in the implanted device The electrical frequency as set in the implanted device Frequency Numeric Values

Record in hertz (Hz)

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

Hertz
C18556 Device implanted intolerable stimulation adverse effect modification description text DevImpIntoleStimAEModDescTxt The reason for modification of original parameters or original electrode configuration of implanted device due to intolerable stimulation related Adverse Event (AE), specification The reason for modification of original parameters or original electrode configuration of implanted device due to intolerable stimulation related Adverse Event (AE), specification Intolerable Stimulation Related Adverse Event, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Implanted Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C14507 Device implanted pulse width value DevImpPulseWidthVal The width of the electrical pulse as set in the implanted device The width of the electrical pulse as set in the implanted device Pulse Width Numeric Values

Record in microseconds (uSec)

McGraw-Hill Dictionary of Scientific and Technical Terms, 5th Edition, Sybil P. Parker, editor, McGraw-Hill, New York, 1994 Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

microsecond
C18557 Device implanted log line number DevImpLogLineNum The reference line number of the entry on the implanted device log. The reference line number of the entry on the implanted device log. Line number Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

0 20
C14508 Device implanted stimulation on duration DevImpStimulationOnDur Time in minutes of stimulation when the implanted device is on Time of stimulation when the implanted device is on Stimulation Duration ON Numeric Values

Record in minutes (mins)

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

minute
C18558 Device implanted other adverse effect modification description text DevImpOthAEModDescTxt The reason for modification of original parameters or original electrode configuration of implanted device due to other Adverse Event (AE), specification The reason for modification of original parameters or original electrode configuration of implanted device due to other Adverse Event (AE), specification Other Adverse Event, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Implanted Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C14509 Device implanted stimulation off duration DevImpStimulationOffDur Time in minutes of stimulation when the implanted device is off Time of stimulation when the implanted device is off Stimulation Duration OFF Numeric Values

Record in minutes (mins)

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

minute
C18559 Device implanted serious adverse effect modification description text DevImpSAEModDescrTxt The reason for modification of original parameters or original electrode configuration of implanted device due to serious device adverse effect(s) specification The reason for modification of original parameters or original electrode configuration of implanted device due to serious device adverse effect(s) specification Serious Adverse Device Effect(s), specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Implanted Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C14510 Device implanted positive electrode count DevImpPosElectrodesCt The number of positive electrodes used by the implanted device The number of positive electrodes used by the implanted device Positive Electrode Numeric Values

Indicate number of positive electrodes, if applicable

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

C18954 Device implanted modification other text DevImpModOTH The free-text field related to 'Device implanted modification reason' specifying other text. The reason for modification of parameters or electrode configuration of original implanted device The free-text field related to 'Device implanted modification reason' specifying other text. The reason for modification of parameters or electrode configuration of original implanted device Other, specify Alphanumeric

Indicate the reason for device modification. Choose all that apply.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data 4000

Free-Form Entry

C14511 Device implanted positive electrode location text DevImpPosElectrodesLocTxt The location of positive electrodes from the implanted device The location of positive electrodes from the implanted device Positive Electrode Alphanumeric

Indicate location of positive electrodes, if applicable

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C18955 Device implanted other text DevImpOTH The free-text field related to 'Device implanted type' specifying other text. The type of device used The free-text field related to 'Device implanted type' specifying other text. The type of device used Other, specify Alphanumeric

Link to line number on the Devices Log form

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data 4000

Free-Form Entry

C14512 Device implanted negative electrode count DevImpNegElectrodesCt The number of negative electrodes used by the implanted device The number of negative electrodes used by the implanted device Negative Electrode Numeric Values

Indicate number of negative electrodes, if applicable

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

C14502 Device start date and time DevStrtDateTime Date (and time, if applicable and known) the device was functional and therapy was started with the parameters specified The date the device was functional and therapy was started with the parameters specified Start Date Date or Date & Time

Record the date the implanted device started to provide therapy. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

C14513 Device implanted negative electrode location text DevImpNegElectrodesLocTxt The location of negative electrodes from the implanted device The location of negative electrodes from the implanted device Negative Electrode Alphanumeric

Indicate location of negative electrodes, if applicable

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C14503 Device implanted removal date DevImpRemovalDate The date the device no longer provided therapy according to the parameters specified The date the device no longer provided therapy according to the parameters specified Stop Date Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

C14514 Device implanted modification reason DevImpModRsn The reason for modification of parameters or electrode configuration of original implanted device The reason for modification of original parameters or original electrode configuration of implanted device If applicable, reason for modifying parameters or electrode configuration Serious device adverse effect(s), specify;Intolerable stimulation related adverse event, specify;Other adverse event, specify;Inadequate Seizure Control;Other, specify Serious device adverse effect(s), specify;Intolerable stimulation related adverse event, specify;Other adverse event, specify;Inadequate Seizure Control;Other, specify Alphanumeric

Indicate the reason for device modification. Choose all that apply.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C14504 Device implanted amperage value DevImpAmperageVal The electrical amperage (amplitude) as set in the implanted device (strength of the electric current) The electrical amperage as set in the implanted device Amplitude Numeric Values

Record in mA

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

milliampere
C14515 Device implanted type DevImpTyp The type of device used The type of device used Device VNS;DBS;RNS;Other, specify VNS (Vagus Nerve Stimulation);DBS (Deep Brain Stimulation);RNS (Responsive Neurostimulation System);Other, specify Alphanumeric

Link to line number on the Devices Log form

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C14505 Device implanted voltage value DevImpVoltageVal The electrical voltage as set in the implanted device (strength of the electric current) The electrical voltage as set in the implanted device Voltage Numeric Values

Record in volts (V)

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Implanted Devices Log Devices Treatment/Intervention Data

Free-Form Entry

Volt
CSV