Device Dossier
Plexa ProMRI SD - Lead, defibrillator, implantable
Device Dossier for Plexa ProMRI SD - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor Biotronik). ARTG record,…
- GMDN category: Lead, defibrillator, implantable
Intended purpose
In combination with a compatible ICD, this lead is designed for the following: • Permanent sensing and pacing in the right ventricle • Delivery of defibrillation / cardioversion therapies
Functional description
The lead body consists of a coil made embedded in silicone. It has 1 RV shock coil, 1 RA shock coil and and the tip is an extendable /retractable screw (distal pole), for fixating in the myocardium. It has a DF4 connector. Bipolar sensing and pacing in the ventricle, between the distal pole and ventricular ring electrode. The leads coating improves gliding properties. Steroid reduces inflammation and threshold increase after implantation. Conditionally MRI compatible.