Streamline Temporary Pacing Leads: Intended Use

PEDIATRIC 6491 - Model 6491 Unipolar Pediatric Temporary Pacing Lead

The Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

ATRIAL 6492 – Model 6492 Unipolar Temporary Atrial Pacing Lead

The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

CONVENIENCE 6494 – Model 6494 Unipolar Temporary Myocardial Pacing Wire

The Model 6494 Unipolar Temporary Myocardial Pacing Wire is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

BIPOLAR COAXIAL 6495 – Model 6495 Bipolar Temporary Myocardial Pacing Lead

The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

PREMIUM 6500 – Model 6500 Unipolar Temporary Myocardial Pacing Lead

The Model 6500 Unipolar Temporary Myocardial Pacing Lead is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

The following information applies to all Streamline™ models.

Contraindications

There are no known general contraindications to temporary post-surgical pacing. The particular medical condition and anatomy of the patient, however, may dictate the lead system and implantation procedure to be used.

Warnings

An implanted pacing lead forms a direct current path to the myocardium. During pacing lead insertion and testing, use only battery-powered equipment specially designed for this purpose, to protect against fibrillation that may be caused by alternating currents.

Line-powered equipment used in the vicinity of the patient must be properly grounded.

Pacing lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment.

Avoid the possibility of unintentional contact between the pacing lead(s), including extension cable, and any equipment used as well as any conductive surface contact.

Leaving the lead implanted for longer than 7 days may result in difficulty or inability to extract the lead and/or bleeding.

Equipment/accessories connected to the Model 6495 shall comply with IEC 601-1-1, type CF.

Potential Complications

The possibility of dislodgement, lead fractures, threshold elevation and sensing inconsistency exists. Other potential complications include, but are not limited to, myocardial irritability, septicaernia and myocardial infections, myocardial bleeding and damage, especially during removal of the pacing lead(s).

Precautions

It is recommended that defibrillation equipment is readily available during temporary pacing lead insertion and removal.

The packaging should be inspected prior to use. Should the seal or package be damaged, contact the local Medtronic representative.

This product should not be exposed to temperatures above 60°C (140°F)

Resterilization

The temporary pacing lead has been ethylene-oxide sterilized prior to shipment. Do not resterilize. Expired products shall be discarded.