CDE Detailed Report
Disease: Epilepsy
Subdomain Name: Devices
CRF: Device Revision
Displaying 1 - 27 of 27
Subdomain Name: Devices
CRF: Device Revision
Displaying 1 - 27 of 27
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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| 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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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 lo | 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 |
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| 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 |
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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 |
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 |
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| 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 |
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| 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 |
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| 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 |
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| C14533 | Device implanted revision component registration number | DevImpRevisionCompRegistratNum | The registration number or serial number of the new component | The registration number or serial number of the new componen | 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
