Example Reported LLT Selected Patient with a vascular implant developed Vascular implant infection an infection of the implant Patient noted the prosthesis caused pain Medical device pain If there is no single MedDRA term reflecting the device-related event and the clinical consequence, select separate terms for both. Example Reported LLT Selected Device malfunction Ventricular tachycardia due to malfunction of device Ventricular tachycardia Dental prosthesis breakage Partial denture fractured leading to tooth pain Tooth pain Device-related event reported without clinical consequences If a device-related event is reported in the absence of clinical consequences, select the appropriate term. Example Reported LLT Selected Medical device breakage Device breakage My patch is leaking on my arm Leaking patch Drug Interactions This term includes reactions between drugs and other drugs, food, devices and alcohol. In this document, includes biologic products. “drug” Labelled drug interactions may be medication errors (see Section 3.15.1.3). Reporter specifically states an interaction Select an interaction term and additional term(s) for any reported medical event. Example
Example Reported LLT Selected Patient with a vascular implant developed an infection of the implant Vascular implant infection Patient noted the prosthesis caused pain Medical device pain If there is no single MedDRA term reflecting the device-related event and the clinical consequence, select separate terms for both. Example Reported LLT Selected Ventricular tachycardia due to malfunction of device Device malfunction Ventricular tachycardia Partial denture fractured leading to tooth pain Dental prosthesis breakage Tooth pain Device-related event reported without clinical consequences If a device-related event is reported in the absence of clinical consequences, select the appropriate term. Example Reported LLT Selected Medical device breakage Device breakage My patch is leaking on my arm Leaking patch Drug Interactions This term includes reactions between drugs and other drugs, food, devices and alcohol. In this document, “drug” includes biologic products. Labelled drug interactions may be medication errors (see Section 3.15.1.3). Reporter specifically states an interaction Select an interaction term and additional term(s) for any reported medical event. Example