Abbott Proclaim 3660 Clinician Manual page 47

Table 22. Summary of non-study related SAEs
Event Description
Following activation
Bladder tumor
Broken femur
Cancerous tumor on vocal chords
Death d
Infection
Loss of speech and memory, and
headache
Myocardial infarction
Scheduled right total-knee
arthroplasty
Seizure
Shortness of breath
Somnolence (sleepiness)
Temporary paralysis
Withdrawal symptoms from
tapering off of oxymorphone*
Total
* The generic name of the medication, oxymorphone, is used instead of the brand name.
** Some subjects experienced more than one event; therefore, the number of subjects
experiencing an event is not equal to the number of events in the neighboring column.
a Subjects at risk out of all subjects enrolled in study
b Subjects at risk out of subjects who completed the week-24 visit
c
Subjects at risk out of all subjects who had the implanted system activated
d Subject died of natural causes at home. No autopsy was performed.
Number of Number of
Events Subjects
1
1
1
1
1
1
1
1
1
1
1
1
1
19
43
Percent of
Subjects (n/N)
1 1.04% (1/96)
1 1.04% (1/96)
1 1.00% (1/100)
1 1.04% (1/96)
1 1.00% (1/100)
1 1.00% (1/100)
1 1.04% (1/96)
1 1.00% (1/100)
1 1.04% (1/96)
1 1.00% (1/100)
1 1.00% (1/100)
1 1.00% (1/100)
1 1.00% (1/100)
8.67%
15**
(15/173)
b
b
c
b
c
c
b
c
b
c
c
c
c