CDE Detailed Report

Disease: Epilepsy
Sub-Domain: Devices
CRF: Device Revision

Displaying 1 - 27 of 27
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
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 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

C18577 Device implanted other new component registration number DevImpOthNewCompRegNum The registration number of the other, unspecified new component The registration number of the other, unspecified new component Device registration number of new component Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

C18565 Device implanted nerve stimulator revision component type DevImpNervStimRevisCompTyp The modification of implanted nerve stimulator (INS) components including explant, replacement, and repositioning The modification of the INS components including explant, replacement, and repositioning INS Explant and replace on same day;Explant only;Replacement only;Repositioned Explant and replace on same day;Explant only;Replacement only (previously explanted);Repositioned Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C18578 Device implanted other revision component type DevImpOthRevisCompTyp The modification of the other, unspecified component including explant, replacement, and repositioning The modification of the other, unspecified component including explant, replacement, and repositioning Other Explant and replace on same day;Explant only;Replacement only;Repositioned Explant and replace on same day;Explant only;Replacement only (previously explanted);Repositioned Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

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

Record the type of device. (Link to line number on Devices Log form). Core for all prospective intervention studies

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

Single Pre-Defined Value Selected

C18567 Device implanted left extension revision component type DevImpLftExtRevisCompTyp The modification of the left extension component including explant, replacement, and repositioning The modification of the left extension component including explant, replacement, and repositioning Extension (LEFT) if applicable Explant and replace on same day;Explant only;Replacement only;Repositioned Explant and replace on same day;Explant only;Replacement only (previously explanted);Repositioned Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C18579 Device implanted right extension revision component type DevImpRtExtRevisCompTyp The modification of the right extension component including explant, replacement, and repositioning The modification of the right extension component including explant, replacement, and repositioning Extension (RIGHT) if applicable Explant and replace on same day;Explant only;Replacement only;Repositioned Explant and replace on same day;Explant only;Replacement only (previously explanted);Repositioned Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C14529 Device implanted revision modification date DevImpRevisionModDate Date (and time, if applicable and known) of the device revision if replacement or modification occurred Date of the device revision if replacement or modification occurred Date of Revision Date or Date & Time

Record the date of device revision. 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 Device Revision/Replacement Log Devices Treatment/Intervention Data

Free-Form Entry

C18568 Device implanted left lead revision component type DevImpLftLeadRevisCompTyp The modification of the left lead component including explant, replacement, and repositioning The modification of the left lead component including explant, replacement, and repositioning Lead (LEFT) Explant and replace on same day;Explant only;Replacement only;Repositioned Explant and replace on same day;Explant only;Replacement only (previously explanted);Repositioned Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C18580 Device implanted right lead revision component type DevImpRtLeadRevisCompTyp The modification of the right lead component including explant, replacement, and repositioning The modification of the right lead component including explant, replacement, and repositioning Lead (RIGHT) if applicable Explant and replace on same day;Explant only;Replacement only;Repositioned Explant and replace on same day;Explant only;Replacement only (previously explanted);Repositioned Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C14530 Device implanted revision component type DevImpRevisionCompTyp The name of the components of the device that were modified or replaced The name of the components of the device that were modified or replaced Device component INS;Lead (LEFT);Lead (RIGHT) if applicable;Extension (LEFT) if applicable;Extension (RIGHT) if applicable;Other Implanted Nerve Stimulator (INS);Lead (LEFT);Lead (RIGHT) if applicable;Extension (LEFT) if applicable;Extension (RIGHT) if applicable;Other Alphanumeric

Choose all components modified

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

Multiple Pre-Defined Values Selected

C18569 Device implanted new extension component model number DevImpnewExtCompModNum The model number of the new extension component The model number of the new extension component Model number of new extension Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

C18582 Device revision replacement log line number DevRevReplaceLogLineNum The referenced line number of the entry on the device revision replacment log. The referenced line number of the entry on the device revision replacment log. Line number Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data

Free-Form Entry

0 20
C14531 Device implanted revision modification type DevImpRevisionModTyp The modification of the components including explant, replacement, and repositioning The modification of the components including explant, replacement, and repositioning Device revision Explant and replace on same day;Explant only;Replacement only;Repositioned Explant and replace on same day;Explant only;Replacement only (previously explanted);Repositioned Alphanumeric

Choose only one for each component

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

Single Pre-Defined Value Selected

C18570 Device implanted new extension component registration number DevImpNewExtCompRegNum The registration number of the new extension component The registration number of the new extension component Device registration number of new extension Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement 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

Record the type of device. (Link to line number on Devices Log form). Core for all prospective intervention studies

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

Free-Form Entry

C14532 Device implanted revision component model number DevImpRevisionCompModelNum The model number, lot number, or serial number of the replacement/new component The model number of the replacement/new component Model number of new component Alphanumeric

Indicate the model number of new component. May also be lot or serial number.

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

Free-Form Entry

C18571 Device implanted nerve stimulator new component model number DevImpNervStimNewCompModelNum The model number of the new implanted nerve stimulator (INS) component The model number of the new INS component Model number of new INS Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

C18960 Device implanted revision or replacement other text DevImpRevisionReplacementOTH The free-text field related to 'Device implanted revision or replacement reason' specifying other text. The reason for device revision/replacement The free-text field related to 'Device implanted revision or replacement reason' specifying other text. The reason for device revision/replacement Other, specify Alphanumeric

Indicate the reason for device revision or replacement

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

Free-Form Entry

C14533 Device implanted revision component registration number DevImpRevisionCompRegistratNum The registration number or serial number of the new component. The registration number of the new component. Could also be lot or serial number. Device registration number of new component Alphanumeric

Indicate device registration number of new component. May also be lot or serial number.

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

Free-Form Entry

C18572 Device implanted nerve stimulator new component registration number DevImpNervStimNewCompRegNum The registration number of the new implanted nerve stimulator (INS) component The registration number of the new INS component Device registration number of new INS Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

C14534 Device implanted revision or replacement reason DevImpRevisionReplacementRsn The reason for device revision/replacement The reason for device revision/replacement Clinical Condition If applicable, reason for the device revision/replacement 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 revision or replacement

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

Single Pre-Defined Value Selected

C18573 Device implanted new lead component model number DevImpNewLeadCompModNum The model number of the new lead component The model number of the new lead component Model number of new lead Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

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 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

C18574 Device implanted new lead component registration number DevImpNewLeadCompRegNum The registration number of the new lead component The registration number of the new lead component Device registration number of new lead Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

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 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

C18576 Device implanted other new component model number DevImpOthNewCompModNum The model number of the other, unspecified new component The model number of the other, unspecified new component Model number of new component Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Device Revision/Replacement Log Devices Treatment/Intervention Data 255

Free-Form Entry

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