Presentation of individual case histories: This section of PSUR shall include the individual case information available to a licence holder and provide brief case narrative, medical history indication treated with suspect medical device, causality assessment and provide following information:— (i) Reference prescribing information (ii) Individual cases received from India (iii) Individual cases received from rest of the world (iv) Cumulative and interval summary tabulations of serious adverse events from clinical investigations (v) Cumulative and interval summary tabulations from postmarketing data sources