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ICD Leads from Boston Scientific

Indications, Safety and Warnings

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Indications

ICD leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for ICD systems.

Contraindications

Use of ICD leads are contraindicated in: patients who have a unipolar pacemaker, patients with a hypersensitivity to a single dose of approximately 1.0 mg of dexamethasone sodium phosphate and/or 1.0 mg of dexamethasone acetate, patients with mechanical tricuspid heart valves.

Warnings

Do not attempt to use the lead system with any device other than a commercially available ICD with which it has been tested and demonstrated safe and effective. Potential adverse consequences include, but are not limited to, undersensing of cardiac activity and failure to deliver necessary therapy. The safety and efficacy of the tip electrode placement above midseptum has not been clinically established (extendable retractable helix leads). Lead fracture, dislodgment, abrasion and/or incomplete connection can cause a periodic or continual loss of rate-sensing, possibly resulting in inappropriate delivery of a PG shock or inadequate delivery of conversion energy. The lead is not designed to tolerate excessive flexing, bending or tension. This could cause structural weakness, conductor discontinuity and/or lead dislodgment. Failure to obtain appropriate electrode position may result in higher defibrillation thresholds or may render lead unable to defibrillate a patient whose tachyarrhythmia(s) might otherwise be convertible by an ICD system. In order to deliver defibrillation therapy, the single-coil lead must be implanted with a separate defibrillation electrode. Boston Scientific CRM recommends using the single-coil lead with a pectorally implanted device that uses the metallic housing as a defibrillation electrode. When connecting the lead to ECD cables and/or the ICD PG it is very important that proper connections are made. Damage to the heart could result if a highvoltage defibrillating pulse were to be delivered through the pace/sense tip electrode. Use of any component of the lead system to assist in the delivery of external-source rescue shocks could cause extensive tissue damage. Do not kink, twist, or braid the lead terminals as doing so could cause lead insulation abrasion damage.

Precautions

Refer to the lead product labeling for cautions specific to handling, implanting and testing the lead. Failure to observe these cautions could result in incorrect lead implantation, lead damage, and/or harm to the patient. It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone sodium phosphate/acetate apply to the use of the low concentration, highly localized, controlled-release device. For a listing of potentially adverse effects, refer to the Physician’s Desk Reference. Tricuspid valvular disease may be exacerbated by the presence of a lead. Use medical judgment when deciding to place a lead in a patient with triscuspid valvular disease. The lead and its accessories are intended only for one-time use. Do not reuse.

Potential Adverse Events

Potential adverse events from implantation of the ICD lead system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, and component failure. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/ precautions and adverse events. Rx only. (Rev. M)
 

Endotak Reliance™ G/SG Leads with DF4-LLHH and DF4-LLHO connectors from Boston Scientific

Indications

Endotak Reliance™ G/SG leads with Integrated Bipolar DF4-LLHH and DF4-LLHO connectors is intended for pacing, rate-sensing and delivery of cardioversion and defibrillation shocks when used with a compatible pulse generator.

Contraindications

Use of ICD leads are contraindicated in: patients who have a unipolar pacemaker, patients with a hypersensitivity to a maximum single dose of 1.3 mg dexamethasone acetate, and patients with mechanical tricuspid heart valves.

Warnings

Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. For single patient use only Do not reuse, reprocess, or resterilize. Always have external defibrillation protection available during implant. Do not use any component of the lead system to assist in delivery of external-source rescue shocks. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing. Lead fracture, dislodgment, abrasion, or an incomplete connection can cause a periodic or continual loss of pacing or sensing or both. The lead is not designed to tolerate excessive flexing, bending, or tension. Do not kink, twist, or braid the lead with other leads. The safety and efficacy of the tip electrode placement above midseptum has not been clinically established. In order to deliver defibrillation therapy, the single-coil models must be implanted with an additional defibrillation electrode. Use fluoroscopy to verify that the lead tip is directed toward the apex when implanted. Take care to obtain appropriate electrode position. When connecting the lead to the pulse generator, it is very important that proper connections are made. Do not expose a patient to MRI device scanning. Do not subject a patient with an implanted pulse generator and/or lead to diathermy.

For DF4-LLHH or DF4-LLHO leads, use caution handling the lead terminal when the Connector Tool is not present on the lead and do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4-LLHH or DF4-LLHO lead terminal, other than the terminal pin even when the lead cap is in place. Only use the Connector Tool for electrical connections to pacing system analyzers or similar monitors. Do not attach alligator clips directly to the lead terminal or damage could occur.

Precautions

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization and storage, handling; implantation, hospital and medical environments, follow-up testing, explant and disposal.

Potential Adverse Events

Potential adverse events from implantation of the ICD lead system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, and component failure. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/ precautions and adverse events. Rx only. (Rev. C)

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