Device And Device Usage Data - Abbott Proclaim 3660 Clinician Manual

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)
Surgery
Number of leads implanted
Mean ± SD (N)
Minimum, Median, Maximum
1 lead
2 leads
3 leads
4 leads
IPG placement side
Left
Right
IPG anatomic location
Abdomen
Lower axilla
Upper buttock
Other
Missing
Arm 1: Tonic/Burst
(N=45)
1.8±0.7 (45)
1.0, 2.0, 4.0
16/45 (35.6%)
26/45 (57.8%)
1/45 (2.2%)
2/45 (4.4%)
39/45 (86.7%)
6/45 (13.3%)
1/45 (2.2%)
0/45 (0.0%)
35/45 (77.8%)
9/45 (20.0%)
0/45 (0.0%)
46
Arm 2: Burst/Tonic
(N=55)
1.7±0.8 (55)
1.0, 2.0, 4.0
22/55 (40.0%)
27/55 (49.1%)
4/55 (7.3%)
2/55 (3.6%)
44/55 (80.0%)
11/55 (20.0%)
2/55 (3.6%)
1/55 (1.8%)
38/55 (69.1%)
13/55 (23.6%)
1/55 (1.8%)