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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Epilepsy
Sub-Domain: Devices
CRF: Device Revision/Replacement Log
Item count: 27 (27 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C18955
Device implanted other text
DevImpOTH
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
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C14515
Device implanted type
DevImpTyp
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
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
Device type
 
Single Pre-Defined Value Selected
       
C18582
Device revision replacement log line number
DevRevReplaceLogLineNum
The referenced line number of the entry on the device revision replacment log.
Line number
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
  
Free-Form Entry
0
20
     
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 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
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
Device revision date and time
 
Free-Form Entry
       
C14530
Device implanted revision component type
DevImpRevisionCompTyp
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
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
Device revision component type
 
Multiple Pre-Defined Values Selected
       
C14531
Device implanted revision modification type
DevImpRevisionModTyp
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
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
Device revision modification type
 
Single Pre-Defined Value Selected
       
C14532
Device implanted revision component model number
DevImpRevisionCompModelNum
The model number, lot number, or serial 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
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
Device revision component model number
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
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 instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C18571
Device implanted nerve stimulator new component model number
DevImpNervStimNewCompModelNum
The model number of the new implanted nerve stimulator (INS) component
Model number of new INS
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
C14533
Device implanted revision component registration number
DevImpRevisionCompRegistratNum
The registration number or serial number of the new component.
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
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
Device revision component registration number
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
Other, specify
  
Alphanumeric
Indicate the reason for device revision or replacement
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C14534
Device implanted revision or replacement reason
DevImpRevisionReplacementRsn
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
3.0
8/28/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
Device revision or replacement reason
 
Single Pre-Defined Value Selected
       
C18572
Device implanted nerve stimulator new component registration number
DevImpNervStimNewCompRegNum
The registration number of the new implanted nerve stimulator (INS) component
Device registration number of new INS
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
C18568
Device implanted left lead revision component type
DevImpLftLeadRevisCompTyp
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 instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
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
Model number of new lead
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
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
Device registration number of new lead
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
C18580
Device implanted right lead revision component type
DevImpRtLeadRevisCompTyp
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 instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
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
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 instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C18569
Device implanted new extension component model number
DevImpnewExtCompModNum
The model number of the new extension component
Model number of new extension
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
C18570
Device implanted new extension component registration number
DevImpNewExtCompRegNum
The registration number of the new extension component
Device registration number of new extension
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
C18579
Device implanted right extension revision component type
DevImpRtExtRevisCompTyp
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 instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
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
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 instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C18576
Device implanted other new component model number
DevImpOthNewCompModNum
The model number of the other, unspecified new component
Model number of new component
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
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
Device registration number of new component
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
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
Serious Adverse Device Effect(s), specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
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
Intolerable Stimulation Related Adverse Event, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Device Revision/Replacement Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
02-21-2017
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