Ventricular tachycardia due to malfunction Device malfunction of device Ventricular tachycardia Partial denture fractured leading to tooth Dental prosthesis breakage 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 Reported LLT Selected Torsade de pointes with suspected Drug interaction drug interaction Torsade de pointes Patient drank cranberry juice which Food interaction interacted with anticoagulant drug causing INR increased an INR increase Reporter does not specifically state an interaction Two products may be used together, but if the reporter does not specifically state that an interaction has occurred, select terms only for the medical events reported. Example Reported LLT Selected Patient was started on an anti-seizure medication and a heart medication and Syncope developed syncope Patient was already on an anti-seizure Anticonvulsant drug level increased
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 Reported LLT Selected Torsade de pointes with suspected drug interaction Drug interaction Torsade de pointes Patient drank cranberry juice which interacted with anticoagulant drug causing an INR increase Food interaction INR increased Reporter does not specifically state an interaction Two products may be used together, but if the reporter does not specifically state that an interaction has occurred, select terms only for the medical events reported. Example Reported LLT Selected Patient was started on an anti-seizure medication and a heart medication and developed syncope Syncope Patient was already on an anti-seizure Anticonvulsant drug level increased
9491-1900_termselptc_r4_11_mar2016_rl.docx