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Page 63 - Abbott
P. 63

    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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