Indications

The ISOLINE Models 2CR and 2CT series leads are indicated for use with ELA Medical implantable defibrillators.

Indications for use of a defibrillator are included in the defibrillator physician’s manual.


Contraindications

Use of the ISOLINE Models 2CR and 2CT series leads are contraindicated for those patients with tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue).

Do not implant in patients for whom < 1.0 mg of dexamethasone sodium phosphate (DSP) is contraindicated.

Contraindications relative to the use of a defibrillator are included in the defibrillator physician’s manual.



WARNINGS AND PRECAUTIONS

Warnings

Properly ground any line-powered equipment used near the patient. Electrosurgical units (e.g., electrocautery) should not be used near an ICD or its associated leads. Currents generated from electrosurgical devices may cause permanent loss of output, induce ventricular fibrillation, or reset programmed parameters in the ICD. If using electrocautery is unavoidable, however, program the Therapy parameters to “Off” and be sure the electrocautery discharge does not make direct contact with the ICD or leads. Following electrocautery, determine the functional integrity of the circuitry and programming. Do not resterilize the lead if sterility is compromised. Return damaged packages to ELA Medical. The ISOLINE Models 2CR and 2CT series leads are for one-time use only. Do not implant an explanted lead in another patient.

Do not kink the lead.
Do not attempt to curve the stylet when it is in the lead.
Do not immerse the lead in mineral oil prior to implant.
Do not attempt to alter the lead in any way.
Use only the appropriate stylets provided by the manufacturer.



Side Effects


Adverse events observed with Isoline 2CT were open RV continuity and suspicion of RV lead dislodgement or migration and open SVC continuity and oversensing. Adverse events observed with Isoline 2CR lead were lead dislodgement or migration, RV oversensing and pericardial effusion.