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Table 13. Serious Adverse Events Over Part 1 and Part 2

Part 1 Part 2
Treatment Control All Patients All Patients
(270) (280) (550) (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Gastric bypass 0 0 1 1 1 1 0 0
Implantable defibrillator insertion 1 1 0 0 1 1 1 1
Incisional drainage 1 1 0 0 1 1 0 0
Knee total replacement 0 0 1 1 1 1 0 0
Mitral valve replacement 0 0 1 1 1 1 0 0
Neuroma removal 1 1 0 0 1 1 0 0
Parotidectomy 0 0 1 1 1 1 0 0
Polypectomy 1 1 0 0 1 1 0 0
Stent placement 1 1 0 0 1 1 0 0
Total hip replacement 1 1 0 0 1 1 0 0
Total knee replacement 0 0 1 2 1 2 0 0
Tricuspid valve repair 0 0 1 1 1 1 0 0
Arteriovenous graft 0 0 0 0 0 0 1 1
Catheterization cardiac 0 0 0 0 0 0 2 2
Hospitalization NOS 0 0 0 0 0 0 1 1
Knee surgery NOS 0 0 0 0 0 0 1 1
Left ventricular assist device insertion 0 0 0 0 0 0 1 1
Ventricular assist device insertion 0 0 0 0 0 0 1 1
Injury, poisoning and procedural 18 21 16 19 34 (6.2%) 40 15 16
complications (6.7%) (5.7%) (4.3%)
Lead dislodgement 2 2 2 2 4 4 0 0
Hip fracture 0 0 3 3 3 3 1 1
Bleeding postoperative 1 1 1 1 2 2 0 0
Device malfunction 0 0 2 2 2 2 0 0
Fall 2 2 0 0 2 2 2 2
Head injury 0 0 2 2 2 2 0 0
Lead conductor fracture 2 2 0 0 2 2 0 0
Subdural hematoma 2 2 0 0 2 2 2 2
Accidental overdose 1 1 0 0 1 1 0 0
Ankle fracture 1 1 0 0 1 1 0 0
Cardiac pacemaker malfunction 0 0 1 1 1 1 0 0
Compression fracture 0 0 1 1 1 1 0 0
Contusion 0 0 1 1 1 1 0 0
Device lead damage 0 0 1 1 1 1 0 0
Device lead issue 1 1 0 0 1 1 0 0
Digoxin toxicity 1 1 0 0 1 1 3 3
Femur fracture 0 0 1 1 1 1 0 0
Fracture rib 1 1 0 0 1 1 0 0
Fractured hip 1 1 0 0 1 1 0 0
Fractured nose 1 1 0 0 1 1 0 0
Fractured pelvis NOS 1 1 0 0 1 1 0 0
Hematoma traumatic 1 1 0 0 1 1 0 0
Humerus fracture 0 0 1 1 1 1 0 0
Medical device complication 0 0 1 1 1 1 0 0
Migration of implant 1 1 0 0 1 1 0 0
Motor vehicle accident 1 1 0 0 1 1 0 0
Pneumothorax traumatic 1 1 0 0 1 1 0 0
Skin avulsion injury 0 0 1 1 1 1 0 0
Subdural haemorrhage 0 0 1 1 1 1 0 0
Chemical pneumonitis 0 0 0 0 0 0 1 1
Device complication 0 0 0 0 0 0 5 5
Overdose accidental 0 0 0 0 0 0 1 1
Sciatic nerve injury 0 0 0 0 0 0 1 1

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