Abbott Proclaim 3660 Clinician Manual page 48

The following table identifies all 62 nonserious AEs that were study-related.
Table 23. Summary of study-related, nonserious AEs (following activation)
Event Description
Charger stopped working
Device pocket heating while
charging
Diminished or loss of stimulation*
Diminished or loss of symptom
relief*
Increased pain
Infection
Local skin erosion
Persistent pain and/or numbness
Postoperative low back pain
Seroma at the implant site
Stimulation in wrong place**
Unpleasant sensations**
Weakness
Total
* Undesirable changes in stimulation
** Unintended effects of stimulation
† Some subjects experienced more than one event.
‡ The total number of subjects who experienced at least one event listed from the previous rows
a
Subjects at risk out of subjects who had the implanted system activated
Number of Number of
Events Subjects
1
1
9
23
1
2
1
6
1
1
6
7
3
62 31
44
Percent of Subjects
1 1.00% (1/100)
1 1.00% (1/100)
†
7 7.00% (7/100)
14 † 14.00% (14/100)
1 1.00% (1/100)
2 2.00% (2/100)
1 1.00% (1/100)
6 6.00% (6/100)
1 1.00% (1/100)
1 1.00% (1/100)
4 † 4.00% (4/100)
6 † 6.00% (6/100)
3 3.00% (3/100)
‡ 31.00% (31/100)
(n/N)
a
a
a
a
a
a
a
a
a
a
a
a
d