Device Events Example 1

This is an example of a study were the sponsor collected Device events associated with the Heatstick System Holder and Charger. The sponsor did not collect device events for the heatstick used in the System Holder and Charger. The International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes was used by the sponsor. Annex A ( 2022) provide the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element. DEDCODE was the Level 3 IMDRF term.

Example ML Variable Metadata [MLDECOD]

Variable	Label	Type	Codelist
DEDECOD	Standardized Meal Name	text	IMDRFANNEXA

Example External Dictionaries

Codelist	External Dictionary Name	Dictionary Version	Reference
IMDRFANNEXA	IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes : Annex A	Release Number: 2022	https://www.imdrf.org/consultations/imdrf-terminologies-categorized-adverse-event-reporting-aer-terms-terminology-structure-and-codes

	Device Experienced Event SPDEVID Pre-populated	HTDDEV
	Device Event Identifier DESPID Hidden/pre-populated	Sponsor-defined
Record a description of the device event that occurred.	Describe the device event. DETERM	_________________
Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY).	What was the start date when the event first occurred or was identified? DESTDAT DESTDTC	_________________
Record how often the incident occurred.	How frequently did the event occur? DEPATT	Single Event Intermittent Continuous
Record what action was taken with the device as a result of the incident.	What action was taken with the study device? DEACNDEV	No change Device replaced <DEACNDEV codelist>
Record the ID of the primary AE associated with the device event, if any.	What was the identifier for the primary adverse event(s) associated with or related to this device event? DEAENO(n) ASSOCIATE WITH RELATED RECORD VIA RELREC	_________________

Order	CDASHIG Variable	Question Text	Prompt	Data Type	CRF Completion Instructions	SDTMIG Target	SDTM Variable Mapping	Controlled Terminology Codelist Name	Permissible Values	Pre-populated Value	List Style	Hidden
1	SPDEVID	What device experienced the event?	Device Experienced Event	text	Indicate the device that was involved in the incident.	SPDEVID				HTDDEV	radio
2	DESPID	What is the device event identifier?	Device Event Identifier	text		DESPID				Sponsor-defined		Y
6	DETERM	Describe the device event.	Device Event	text	Record a description of the device event that occurred.	DETERM
7	DESTDAT	What was the start date when the event first occurred or was identified?	Start Date	text	Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY).	DESTDTC
10	DEPATT	How frequently did the event occur?	Event Frequency	text	Record how often the incident occurred.	DEPATT			Single Event; Intermittent; Continuous		radio
11	DEACNDEV	What action was taken with the study device?	Action Taken With Device	text	Record what action was taken with the device as a result of the incident.	DEACNDEV		(DEACNDEV)	No change; Device replaced;		radio
12	DEAENO(n)	What was the identifier for the primary adverse event(s) associated with or related to this device event?	Related Adverse Event ID	text	Record the ID of the primary AE associated with the device event, if any.	N/A	ASSOCIATE WITH RELATED RECORD VIA RELREC

The associated SDTM datasets for the data collected above are provided below. The DI domain is used to identify the device. Only one device was of interest in the study.

di.xpt

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	TOB07	DI	HTDDEV	1	DEVTYPE	Device Type	Heatstick System Holder and Charger
2	TOB07	DI	HTDDEV	2	MANUF	Manufacturer	Reliable Devices
3	TOB07	DI	HTDDEV	3	MODEL	Model Number	700XYZ

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de.xpt

xx.xpt

Row	STUDYID	DOMAIN	USUBJID	SPDEVID	DESEQ	DETERM	DEDECOD	DEMODIFY	DEVACT	DESTDTC	DEIMDRDC	DEIMDRFL2	DEIMDRFL1
1	TB005	DE	2029	HTDDEV	1	Broken Heater	Mechanical Problem	Mechanical Problem	Device Replaced	2009-12-28	A05	Mechanical Problem	Mechanical Problem
2	TB005	DE	1059	HTDDEV	1	Won’t charge	Charging Problem	Charging Problem	Battery Replaced	2009-01-05	A0706	Charging Problem	Electrical /Electronic Property Problem
3	TB005	DE	3067	HTDDEV	1	Battery Malfunction	Battery Problem	Battery Problem	Battery Replaced	2009-01-05	A0705	Battery Problem	Electrical /Electronic Property Problem

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DE NSV Metadata

Variable	Label	Type	Role	Origin
DEIMDRDC	IMDRF Code	Char	Non-standard Variable Qualifier of DEDECOD	Assigned
DEIMDRFL2	IMDRF Level 2	Char	Non-standard Variable Qualifier of DEDECOD	Assigned
DEIMDRFL1	IMDRF Level 1	Char	Non-standard Variable Qualifier of DEDECOD	Assigned

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Device Events Example 1