Health Impact Information and Clinical Signs and Symptoms Coding

Clinical Signs and Symptoms can be coded in the Events tab by clicking the Select button associated with Clinical Signs IMDRF Code.

Clinical Signs and Symptoms IMDRF are populated in the Section 3.3a: IMDRF ‘Health Effect’ terms and codes (Annex E, F) of the MIR report.

Health Impact Information coding determines the Classification of Incident and this information is crucial for all report types.

It is recommended that the data entry guidelines is updated to ensure at least one Health Impact Information is available for a case which requires MIR Report to be scheduled.

If the Health Impact is coded with the following terms, then respective fields in PDF and XML are affected as indicated in the below table.

All the valid IMDRF codes selected in the Device > Health Impact Information section, are populated in 3.3a section of MIR PDF with the corresponding element in MIR XML.

Health Impact Code available in Health Impact Information Section	Health Impact in Health Impact Information Section in PDF	Value transmitted in MIR XML	Comments
F20	Serious Public Health Threat	Serious Public Health Threat	Second Preference is given to Serious Public Health Threat. If any of the Health Impact information has Serious Public Health Threat and Death not present, Serious Public Health Threat is selected in the Report.
F02	Death	Death	First Preference is given to Death. If any of the Health Impact information has death, regardless of other values Death is selected in the Report.
F21	Unexpected Deterioration	Unanticipated Serious Deterioration in State of Health	Third Preference is given to Unexpected Deterioration, if Death and Serious Public Health Threat is not present in any of the Health Impact information, Unanticipated Serious Deterioration in State of Health is selected in the Report.
Any other Codes	Any other Health Impact Term Coded	All other reportable incidents	Any other health Impact information available, All other reportable incidents is selected in the Report.