Device and Device Usage Data
Surgery and device data were collected for the 100 subjects that were randomized and received a
permanent implant. As shown in the following tables, randomization groups showed a similar
number of implanted leads and similar IPG placement.
Table 25. Summary of surgery and device information for all randomized subjects (N=100)
Arm 1: Tonic/Burst
(N=45)
Arm 2: Burst/Tonic
(N=55)
Number of leads implanted
Mean ± SD (N) 1.8±0.7 (45) 1.7±0.8 (55)
Minimum, Median, Maximum 1.0, 2.0, 4.0 1.0, 2.0, 4.0
1 lead 16/45 (35.6%) 22/55 (40.0%)
2 leads 26/45 (57.8%) 27/55 (49.1%)
3 leads 1/45 (2.2%) 4/55 (7.3%)
4 leads 2/45 (4.4%) 2/55 (3.6%)
IPG placement side
Left
39/45 (86.7%) 44/55 (80.0%)
Right
6/45 (13.3%) 11/55 (20.0%)
IPG anatomic location
Abdomen
1/45 (2.2%) 2/55 (3.6%)
Lower axilla
0/45 (0.0%) 1/55 (1.8%)
Upper buttock
35/45 (77.8%) 38/55 (69.1%)
Other
9/45 (20.0%) 13/55 (23.6%)
Missing
0/45 (0.0%) 1/55 (1.8%)
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