The Medtronic TYRX™ Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
CRITERIA LIST/ QUALIFICATIONS:
Patient is at least 18 years of age and meets age requirements per local law.
Patient has existing CIED and is undergoing ICD or CRT-D replacement or upgrade with a new Medtronic generator.
Patient will be having de novo (first-time) CRT-D system implant.
Patient has existing study eligible Medtronic CIED in which the pocket was not accessed within the last 365 days, and is undergoing pocket or lead revision.
Willing to provide the contact information for the physician who provides follow-up for his/her CIED.
Patient is willing to sign and date the Informed Consent Form.
Patient is willing to comply with scheduled follow-up and study-related activities.