CDE Detailed Report
Disease: content
Subdomain Name: Devices
CRF: welcome
Displaying 1 - 21 of 21
Subdomain Name: Devices
CRF: welcome
Displaying 1 - 21 of 21
| CDE ID | CDE Name | Variable Name | Definition | Short Description | 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 / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 | |||||||||
| 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 devic | 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 |
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| 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 |
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| 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 lo | 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
