Boston Scientific EASYTRAK 2 IS-1, Physician'S Lead Manual

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EASYTRAK 2 IS-1 LEAD—ADVERSE EVENTS
4
In addition to the implantation of an implantable cardioverter defibrillator
and/or pacemaker lead system, possible adverse events associated with
implantation of a coronary venous lead system are listed below in
alphabetical order:
• Allergic reaction to contrast media
• Breakage/failure of implant tools
• Coronary venous occlusion
• Coronary venous trauma (e.g., perforation, dissection, erosion)
• Prolonged exposure to fluoroscopic radiation
• Renal failure from contrast media used to visualize coronary veins
Warranty
See the enclosed Lead Information card for warranty. For additional copies,
please contact Boston Scientific Corporation at the address on the back
cover.
Refer to the Contraindications, Warnings, Precautions, and Adverse Events
sections of this manual for information concerning the performance of this
device.
• Cardiac tamponade • Lead tip deformation and/or
breakage
• Chronic nerve damage • Local tissue reaction
• Conductor coil fracture • Myocardial trauma (e.g., cardiac
perforation, irritability, injury)
• Death • Oversensing/undersensing
• Elevated thresholds • Pneumothorax/hemothorax
• Erosion/extrusion • Random component failures
• Extracardiac stimulation (e.g.,
phrenic, diaphragm, chest wall) • Shunting current or insulating
myocardium during defibrillation
with internal or external paddles
• Fibrotic tissue formation (e.g.,
keloid formation) • Thrombosis/thromboemboli
• Formation of hematomas or
cysts • Venous occlusion
• Inappropriate therapy (e.g.,
shocks, ATP, pacing) • Venous trauma (e.g., perforation,
dissection, erosion)
• Incomplete lead connection with
pulse generator
356995-051 EN Europe.book Page 4 Monday, August 8, 2011 3:43 PM