ICD Leads from Boston Scientific CRM

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 nominal dose of dexamethasone sodium phosphate and/or 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. K)