User Manual Part 1

INFORMATION FOR USE

POTENTIAL ADVERSE EVENTS

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POTENTIAL ADVERSE EVENTS

Based on the literature and on pulse generator implant experience, the

following alphabetical list includes the possible adverse events associated with

implantation of a pulse generator system:

• Air embolism

• Allergic reaction

• Bleeding

• Cardiac tamponade

• Chronic nerve damage

• Component failure

• Conductor coil fracture

•Death

• Electrolyte imbalance/dehydration

• Elevated thresholds

•Erosion

• Excessive ﬁbrotic tissue growth

• Extracardiac stimulation (muscle/nerve stimulation)

• Failure to convert an induced arrhythmia

• Foreign body rejection phenomena

• Formation of hematomas or seromas

• Inability to deﬁbrillate or pace

• Inappropriate therapy (e.g., shocks where applicable, ATP, pacing)

• Incisional pain

• Incomplete lead connection with pulse generator

• Infection

• Insulating myocardium during deﬁbrillation with inte rnal or e xtern al paddles

• Lead dislodgment

• Lead fracture

• Lead insulation breakage or abrasion

• Lead tip deformation and/or breakage

• Myocardial infarction (MI)

• Myocardial necrosis

- DRAFT -