Device Dossier

6996SQ Subcutaneous unipolar lead - Lead, defibrillator, implantable

Device Dossier for 6996SQ Subcutaneous unipolar lead - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor Medtronic).…

Intended purpose

The leads are intended for long-term subcutaneous use when a standard implantable cardioverter defibrillator system with one or more transvenous leads has not been efficacious in providing acceptable defibrillation threshold (DFT) measurements by delivery of cardioversion and defibrillation therapies for the treatment of ventricular tachyarrhythmias.

Functional description

The model 6996SQ lead is a passive fixation unipolar silicon rubber insulated subcutaneous defibrillation lead. It is placed in the posterior section of the thorax and is designed as an alternative to a subcutaneous patch and used solely for defibrillation.

TGA Public Summary