Cardiac Device Manufacturing Glossary

Official communication from device manufacturers to physicians regarding potential safety issues or performance concerns...

Breakdown of tissue overlying an implanted cardiac device, potentially exposing the device or leads.

Regulatory action requiring manufacturer notification and potential device replacement due to safety or performance issu...

Electromagnetic interference between multiple implanted devices affecting function, requiring special consideration in m...

Industry-standard high-voltage connector for defibrillation leads, larger than IS-1 connectors to handle shock delivery.

A device status indicating battery depletion has reached the point where replacement should be scheduled within several...

External electromagnetic fields that can disrupt cardiac device function, requiring specific design considerations and p...

A transvenous cardiac lead positioned inside the heart chambers, in contact with the endocardium.

The minimum electrical energy required to consistently capture the heart muscle through an endocardial lead placed insid...

A pacing lead attached to the outer surface of the heart muscle rather than inserted through blood vessels.

Electrophysiological technique mapping cardiac electrical activity from the heart's outer surface, used in CRT lead plac...

Failure of a paced stimulus to depolarize cardiac tissue despite adequate electrical output from the device.

Detection of cardiac electrical activity from a chamber other than where the sensing electrode is located, potentially c...

Expected operational lifespan of the pulse generator battery, critical for patient counseling and replacement planning d...

The connector assembly of a pulse generator where leads are inserted and secured with set screws.

The maintenance of a completely airtight and moisture-proof barrier in cardiac device enclosures to protect internal ele...

A physiologic pacing technique that directly stimulates the heart's natural conduction system at the His bundle.

Official guidance documents from the Heart Rhythm Society providing clinical recommendations for cardiac device manageme...

A device that monitors heart rhythm and delivers electrical shocks to correct life-threatening arrhythmias.

A clinical study conducted under FDA authorization to evaluate an investigational medical device for safety and effectiv...

Delivery of defibrillation therapy by an ICD for rhythms that do not warrant defibrillation treatment.

Breakdown of the outer coating of a cardiac lead, causing electrical leakage and circuit malfunction.

The process of wirelessly communicating with an implanted cardiac device to retrieve stored data and assess function.

The international standard connector design for cardiac pacing leads, featuring a 3.2mm diameter.