CDE Detailed Report
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 |
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C14515 | Device implanted type | DevImpTyp | The type of device used | The type of device used | Device Name | 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. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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C14527 | Device discontinuation reason | DevDisctRsn | The reason the subject discontinued use of the device | The reason use of the device was discontinued | If applicable, Reason for Discontinuation | 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 reason for discontinuation, if applicable Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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C14516 | Device implanted implant date and time | DevImpImplantDateTime | Date (and time, if applicable and known) the device was implanted and became functional | Date (and time, if applicable and known) the device was implanted and became functiona | Date of Initial Implant | Date or Date & Time |
Record the date of initial implant. Core for all prospective intervention studies. 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 | Devices Log | Devices | Treatment/Intervention Data |
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 | Devices Log | Devices | Treatment/Intervention Data | 255 |
Free-Form Entry |
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C14517 | Device manufacturer name | DevManufName | The company responsible for development of the device | The name of the manufacturer of the device that was placed in the subject's body | Device Manufacturer | Alphanumeric |
Record the device manufacturer. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data | 255 |
Free-Form Entry |
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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 | Devices Log | Devices | Treatment/Intervention Data | 255 |
Free-Form Entry |
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C14518 | Device component type | DevCompTyp | The name of a part of the device that has a registration number or serial number | The name of a part of the device that has a registration number or serial number | Device Component Registration number or Serial number | INS;Lead;Extension | Implanted Nerve Stimulator (INS);Lead;Extension | Alphanumeric |
Select the component(s) of the device as applicable. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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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 | Devices Log | Devices | Treatment/Intervention Data | 255 |
Free-Form Entry |
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C14519 | Device component registration or serial number | DevCompRegstrnSerialNum | The registration number or serial number of the device and component(s) to distinguish it from other devices (extension if applicable) | The registration number or serial number of a part of the device | Device Component Registration number or Serial number | Numeric Values |
Enter all applicable device registration or serial number(s). Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data |
Free-Form Entry |
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C18564 | Device log line number | DevLogLineNum | The referenced line number of the entry on the device log | The referenced line number of the entry on the device lo | Line number | Numeric Values | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-30 14:29:49.047 | Devices Log | Devices | Treatment/Intervention Data |
Free-Form Entry |
0 | 20 | |||||||||
C14520 | Device stimulation target anatomic site | DevStimTargAntmicSite | The target of stimulation the device acts upon (where the device lead is located) | The part of the body the device is stimulating | Stimulation Target | Left Vagus Nerve;Hippocampus;Hippocampus: Left side;Hippocampus: Right side;AN;AN: Unilateral;AN: Bilateral;Other, specify | Left Vagus Nerve;Hippocampus;Hippocampus: Left side;Hippocampus: Right side;AN;AN: Unilateral;AN: Bilateral;Other, specify | Alphanumeric |
Indicate stimulation target of device. Choose only one. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2012-10-05 00:00:00.0 | Devices Log | Devices | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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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. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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C14521 | Device lead type | DevLeadTyp | Type of insulated wires (leads) for the device implanted | Type of insulated wires (leads) | Type of Lead | VNS;Depth;Strip;Other, specify | VNS (Vagus Nerve Stimulation);Depth;Strip;Other, specify | Alphanumeric |
Choose all that apply; if other specify. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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C18956 | Device stimulation target anatomic other text | DevStimTargAntmicOTH | The free-text field related to 'Device stimulation target anatomic site' specifying other text. The target of stimulation the device acts upon (where the device lead is located) | The free-text field related to 'Device stimulation target anatomic site' specifying other text. The target of stimulation the device acts upon (where the device lead is located) | Other, specify | Alphanumeric |
Indicate stimulation target of device. Choose only one. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2012-10-05 00:00:00.0 | Devices Log | Devices | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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C14522 | Device lead contact count | DevLeadContctCt | The number of contacts of the insulated wires (leads) | The number of contacts of the insulated wires (leads) | Number of Contacts | Numeric Values |
Indicate number of contacts for lead, if applicable. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data |
Free-Form Entry |
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C18957 | Device lead other text | DevLeadOTH | The free-text field related to 'Device lead type' specifying other text. Type of insulated wires (leads) for the device implanted | The free-text field related to 'Device lead type' specifying other text. Type of insulated wires (leads) for the device implanted | Type of Lead | Alphanumeric |
Choose all that apply; if other specify. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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C14523 | Device neurostimulator anatomic site | DevNeurostimAntmicSite | The location in the body of where the device is providing electrical stimulation | The location in the body of where the device is providing electrical stimulation | Location of Neurostimulator | Right chest;Left chest;Other, specify | Right chest;Left chest;Other, specify | Alphanumeric |
Choose all that apply; if other specify. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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C18958 | Device neurostimulator anatomic other text | DevNeurostimAntmicOTH | The free-text field related to 'Device neurostimulator anatomic site' specifying other text. The location in the body of where the device is providing electrical stimulation | The free-text field related to 'Device neurostimulator anatomic site' specifying other text. The location in the body of where the device is providing electrical stimulation | Other, specify | Alphanumeric |
Choose all that apply; if other specify. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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C14524 | Device permanent explant date | DevPermExplantDate | Date the device was removed from the subject | Date the device was removed from the subject | Date of Permanent Explant | Date or Date & Time |
As applicable, complete the Implanted Devices Log if (device) not explanted. Core for all prospective intervention studies. 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 | Devices Log | Devices | Treatment/Intervention Data |
Free-Form Entry |
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C18959 | Device discontinuation other text | DevDisctOTH | The free-text field related to 'Device discontinuation reason' specifying other text. The reason the subject discontinued use of the device | The free-text field related to 'Device discontinuation reason' specifying other text. The reason the subject discontinued use of the device | Other, specify | Alphanumeric |
Indicate reason for discontinuation, if applicable Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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C14525 | Device part left in the body indicator | DevPartLftInBodyInd | An indicator of whether any part of the device was left in the subject's body after the device was removed, with identification of the part | An indicator of whether any part of the device was left in the subject's body after the device was removed and identification of the part | Is any part of the device left in the body? | No;Yes | No;Yes | Alphanumeric |
Indicate if any part of device is remaining in body after therapy. Record in the log along with the location of the part. Core for all prospective intervention studies |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Devices Log | Devices | Treatment/Intervention Data |
Single Pre-Defined Value Selected |